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GTDI item MR-1202

Surgical N95 respirator, double-shell, 240 per case

  • NIOSH Approved N95
  • Surgical N95 (FDA Class II)
  • FDA 510(k) cleared

NIOSH Approved surgical N95 filtering facepiece respirator with collapse-resistant double-shell construction, staple-free, with a contoured adjustable nose clip, soft foam nose cushion and polymer head straps; no exhalation valve. Regulated by FDA as a Class II device and 510(k) cleared as a surgical mask. Fluid resistance 160 mm Hg as stated by the manufacturer. Made in the United States, as stated by the manufacturer. 20 respirators per box, 12 boxes (240) per case. Fit testing is model specific; your quote names the exact model.

20 per box, 12 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-1202 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
Exhalation valve No Regulator record
Construction Collapse resistant double-shell construction Manufacturer specification
Staples Staple-free construction Manufacturer specification
Nose clip and cushion Contoured adjustable nose clip; soft foam nose cushion Manufacturer specification
Straps Polymer head straps Manufacturer specification
Performance, testing and labeling
Fluid resistance 160 mm Hg, as stated by the manufacturer 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
Country of origin United States, as stated by the manufacturer Manufacturer specification
Packaging 20 respirators per box, 12 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
One size, 20 per box MR-1202-EA 20 12 240

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
Manufacturer statement
FDA 510(k) cleared as a surgical mask. The 510(k) number is on your quote.Basis: As stated by the manufacturer; the document is supplied with the quote
Manufacturer statement
Provides at least 95% filtration efficiency against certain particles that do not contain oil, as stated by the manufacturer.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

  • 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, 240 per caseGTDI item MR-1202, this page N95, Surgical Collapse resistant double-shell construction One size, 20 per box No 20
N95 respirator, 160 per caseGTDI item MR-1201 Standard 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, cup styleGTDI item MR-1204 N95, Surgical Cup style, collapse resistant Standard; small No 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.

Talk to the accounts team.

Phone, email and address are the same on every page of this site, on every quote and on every invoice.

  • Phone 424-832-6485
  • Email sales@gtdi.net
  • Hours Monday to Friday, 8 a.m. to 5 p.m. Pacific
  • Address GTDI, 200 S Barrington Ave, Los Angeles, CA 90049

Your first contact is the GTDI accounts team. Existing accounts: your representative's direct contact is on your account dashboard.