GTDI item MR-1204

Surgical N95 respirator, cup style, standard and small

NIOSH Approved N95
Surgical N95 (FDA Class II)
FDA 510(k) cleared
Not made with natural rubber latex

NIOSH Approved surgical N95 filtering facepiece respirator with a collapse-resistant cup design, braided stapled headbands and an adjustable nose clip, in standard and small sizes; no exhalation valve. Regulated by FDA as a Class II device and 510(k) cleared as a surgical mask. Fluid resistance 120 mmHg (standard) and 80 mmHg (small) under ASTM F1862, bacterial filtration efficiency above 99% under ASTM F2101 and a Class I flammability rating, as stated by the manufacturer. Shelf life five years from the date of manufacture. Not made with natural rubber latex. 20 respirators per box, 6 boxes per case. Fit testing is model specific; your quote names the exact model.

20 per box, 6 boxes Respirators

Render of a cup-style N95 respirator — Illustration of the product type. The manufacturer and brand are named on your written quote.

Specifications

Attribute, value and basisValues as stated by the manufacturer. The standard or test behind each value is named in the row.
Attribute	Value	Basis
Identity and regulatory status
GTDI item code	MR-1204	Internal
Regulatory status	NIOSH Approved N95 filtering facepiece respirator. Surgical N95: regulated by FDA as a Class II device (21 CFR 878.4040) and 510(k) cleared as a surgical mask. The approval and clearance numbers are on your quote.	The product's own clearance, approval or registration
NIOSH filter class	N95	Regulator record
NIOSH protection type	N95, Surgical	Regulator record
FDA clearance as a surgical mask	Yes; 510(k) cleared as a surgical mask. The 510(k) number is on your quote.	Regulator record
NIOSH approval	NIOSH Approved N95. The TC approval number is on your quote so you can confirm it in NIOSH's list of approved respirators.	Regulator record
Material and construction
Facepiece style	Cup style, collapse resistant	Manufacturer specification
Straps	Braided and stapled headbands; straps to braided polyisoprene; staples to steel	Manufacturer specification
Nose clip and foam	Adjustable nose clip (aluminum); nose foam (polyurethane foam)	Manufacturer specification
Exhalation valve	No	Manufacturer specification
Sizes	Standard; small	Manufacturer specification
Materials, standard size	Filter to polypropylene; shell to polyester; coverweb to polypropylene	Manufacturer specification
Performance, testing and labeling
Fluid resistance, standard size	120 mmHg (ASTM F1862), as stated by the manufacturer	Manufacturer specification
Fluid resistance, small size	80 mmHg, as stated by the manufacturer	Manufacturer specification
Bacterial filtration efficiency	Above 99% (ASTM F2101), as stated by the manufacturer	Manufacturer specification
Flammability	Class I, as stated by the manufacturer	Manufacturer specification
Natural rubber latex	Not made with natural rubber latex	Manufacturer specification
Fit test	Fit testing is model-specific. Tell us the model your staff are fit-tested to. Your quote confirms that exact model or names an alternative for your approval.	29 CFR 1910.134
Storage, origin and packaging
Shelf life	5 years from the date of manufacture	Manufacturer specification
Storage	Store in temperatures between -4°F (-20°C) and +86°F (+30°C)	Manufacturer specification
Country of origin	Confirmed on quote	Confirmed on quote
Packaging	20 respirators per box, 6 boxes per case	Manufacturer specification

Sizes and packaging

Pack-out by size
Size or variant	Variant code	Respirators per pack	Packs per case	Respirators per case
Standard	MR-1204-STD	20	6	120
Small	MR-1204-SM	20	6	120

Standards, testing and claims

NIOSH Approved N95: NIOSH Approved N95. The TC approval number is on your quote so you can confirm it in NIOSH's list of approved respirators.Basis: NIOSH approval record; the TC number is stated on your quote
Surgical N95 (FDA Class II): Basis: NIOSH approval and FDA clearance records, stated on your quote
FDA 510(k) cleared: NIOSH Approved N95 filtering facepiece respirator. Surgical N95: regulated by FDA as a Class II device (21 CFR 878.4040) and 510(k) cleared as a surgical mask. The approval and clearance numbers are on your quote.Basis: FDA 510(k) record; the number is stated on your quote
Not made with natural rubber latex: Basis: Manufacturer labeling; FDA labeling guidance
Manufacturer statement: FDA 510(k) cleared for use as a surgical mask, as stated by the manufacturer.Basis: As stated by the manufacturer; the document is supplied with the quote
Manufacturer statement: Fluid resistant under ASTM F1862, as stated by the manufacturer.Basis: As stated by the manufacturer; the document is supplied with the quote
Manufacturer statement: Bacterial filtration efficiency above 99% under ASTM F2101, as stated by the manufacturer.Basis: As stated by the manufacturer; the document is supplied with the quote
Manufacturer statement: Meets the NIOSH 42 CFR part 84 N95 requirement of at least 95% filtration efficiency.Basis: As stated by the manufacturer; the document is supplied with the quote

NIOSH Approved N95 filtering facepiece respirator. Surgical N95: regulated by FDA as a Class II device (21 CFR 878.4040) and 510(k) cleared as a surgical mask. The approval and clearance numbers are on your quote.

Provided with your quote

Spec sheet Supplied with your written quote, before you order With the quote
Brochure Supplied with your written quote, before you order With the quote
FDA database record Supplied with your written quote, before you order With the quote
NIOSH Certified Equipment List entry Supplied with your written quote, before you order With the quote

We substitute only with your written approval. A change of manufacturer counts as a substitution.

Compare with other n95 respirators

N95 respiratorsValues as each product page states them. An empty cell means the manufacturer states no value.
Product	Type	Shape	Sizes	Exhalation valve	Per box
Surgical N95 respirator, cup styleGTDI item MR-1204, this page	N95, Surgical	Cup style, collapse resistant	Standard; small	No	20
N95 respirator, 160 per caseGTDI item MR-1201			Standard	No	20
Surgical N95 respirator, 240 per caseGTDI item MR-1202	N95, Surgical	Collapse resistant double-shell construction	One size, 20 per box	No	20
N95 respirator, molded shellGTDI item MR-1203		Molded outer shell	Medium/large; small; a third size as labeled by the manufacturer, confirmed on your quote	No exhalation valve	20
Surgical N95 respirator, flat foldGTDI item MR-1205	N95, Surgical	Three-panel flat fold	One size, 20 per box	No	20
Surgical N95 respirator, pouch styleGTDI item MR-1206	N95, Surgical	Pouch style (expanded chamber)	Regular; small	No	35

All n95 respirators

Questions buyers ask about masks and respirators

Tell us the model your staff are fit-tested to. The quote confirms that exact model or names an alternative for your approval.
Valved models are not for sterile fields. Surgical N95 models are always unvalved.
Past its shelf life a respirator is no longer NIOSH Approved. Rotate stock by date.

Do we need a fluid barrier or airborne protection?

A mask protects against splashes and large droplets and is an FDA device under 21 CFR 878.4040. A respirator filters airborne particles and is approved by NIOSH under 42 CFR part 84. The task decides which, and the two are never interchangeable.

Which ASTM level suits which task?

ASTM F2100 rates masks at Level 1, 2 or 3 on bacterial and particulate filtration, breathability and resistance to synthetic blood at 80, 120 or 160 mmHg. Higher fluid resistance suits procedures with splash risk. Each listing shows the level and the test values behind it, as the edition on the manufacturer's test report states them.

Is this respirator NIOSH Approved, and how do we check?

Every respirator listed as N95 holds a current NIOSH approval. The TC approval number is on your quote so you can confirm it on the NIOSH Certified Equipment List. NIOSH treats "N95" and "NIOSH Approved" as registered certification marks, and a product without an approval may not carry them.

Surgical N95 or standard N95?

A surgical N95 is a NIOSH Approved respirator that is also fluid resistant and regulated by FDA as a Class II device. It is unvalved and states its fluid resistance level. A standard N95 is NIOSH Approved only. Sterile fields and procedure rooms call for the surgical version.

Is this the model our staff are fit-tested to?

Fit testing applies to the make, model, style and size tested. Tell us the model your staff are fit-tested to. Your quote confirms that exact model or names an alternative for your approval, and nothing is substituted without it.

What is the shelf life, and how do we rotate a stockpile?

Manufacturers set a shelf life, often about five years. Past its shelf life a respirator is no longer NIOSH Approved. Each listing shows the shelf life as stated, and quotes state the dating at shipment, so a stockpile can be rotated by date.

When is a KN95 acceptable?

A KN95 is made to China's GB 2626 standard and is not NIOSH Approved. It is listed plainly as such and is not for use where a NIOSH Approved respirator is required.

Cross-reference

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We substitute only with your written approval. A change of manufacturer counts as a substitution.

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