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GTDI item GA-1104

AAMI Level 2 isolation gown, SMS, thumb loop, yellow

  • ANSI/AAMI PB70 Level 2
  • FDA Class I device, exempt from 510(k)

Isolation gown of multilayer SMS nonwoven that the manufacturer states is ANSI/AAMI PB70 Level 2 compliant for isolation, in an over-the-head style with thumb-loop wrists, side ties, full back coverage and sealed seams. Yellow, non-sterile, in regular and XL; described by the manufacturer as medium weight. Non-surgical isolation gown; FDA Class I medical device, exempt from 510(k). 100 gowns per case.

100 per case Gowns and apparel
Render of a yellow isolation gown with thumb cuffs
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 GA-1104 Internal
Regulatory status Non-surgical isolation gown. FDA Class I medical device, exempt from 510(k). The product's own clearance, approval or registration
AAMI PB70 barrier level Level 2 Manufacturer specification
Material and construction
Material Multilayer SMS nonwoven, described by the manufacturer as medium weight Manufacturer specification
Wrists Thumb loop wrists Manufacturer specification
Closure Side ties; over-the-head style (no neck closure) Manufacturer specification
Back Full Back Manufacturer specification
Sizes Regular; XL Manufacturer specification
Color Yellow Manufacturer specification
Seams Sealed seams, as stated by the manufacturer Manufacturer specification
Performance, testing and labeling
Sterile No Manufacturer specification
Disposable Yes Manufacturer specification
Storage, origin and packaging
Country of origin Confirmed on quote Confirmed on quote
Packaging 100 gowns per case Manufacturer specification

Sizes and packaging

Pack-out by size
Size or variant Variant code Gowns per case
Regular GA-1104-REG 100
XL GA-1104-XL 100

Standards, testing and claims

ANSI/AAMI PB70 Level 2
FDA Class I device, exempt from 510(k)
Non-surgical isolation gown. FDA Class I medical device, exempt from 510(k).Basis: FDA device classification
Manufacturer statement
Made from a multilayer nonwoven material that is ANSI/AAMI PB70 Level 2 compliant for isolation, as stated by the manufacturer.Basis: As stated by the manufacturer; the document is supplied with the quote

Non-surgical isolation gown. FDA Class I medical device, exempt from 510(k).

Provided with your quote

  • Document 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 isolation gowns

Isolation gownsValues as each product page states them. An empty cell means the manufacturer states no value.
Product Material Cuff Color Sizes Per case
AAMI Level 2 isolation gown, thumb loopGTDI item GA-1104, this page Multilayer SMS nonwoven, described by the manufacturer… Thumb loop wrists Yellow Regular; XL 100
Film isolation gown, thumb loop, blueGTDI item GA-1101 Chlorinated polyethylene (CPE) film Thumb Loop Blue Universal 75
AAMI Level 2 isolation gown, SMSGTDI item GA-1102 Three-layer SMS: spunbond polypropylene outer layers… Elastic Yellow; blue Large; X-Large 100
AAMI Level 3 isolation gown, SMSGTDI item GA-1103 Three-layer SMS: spunbond polypropylene outer layers… Elastic Blue Large; X-Large 100

All isolation gowns

Questions buyers ask about gowns and apparel

  • Look for labeling that states the gown's intended use and level of protection, as FDA advises.
  • Film gowns with thumb loops carry much of the Enhanced Barrier Precautions volume at low cost.
Which AAMI level does the task need?

ANSI/AAMI PB70 sorts protective apparel into four levels. Level 1 suits basic care and standard isolation, Level 2 blood draws and the intensive care unit, Level 3 arterial draws, IV insertion and trauma, Level 4 long fluid-intense procedures and surgery. The level a task calls for is your facility's decision, and each listing states the level as labeled.

Isolation gown or surgical gown?

A surgical gown is sterile, labeled as a surgical gown and 510(k) cleared, with critical zones on the front. A surgical isolation gown is also 510(k) cleared, with critical zones everywhere except bindings, cuffs and hems. A non-surgical isolation gown is Class I and exempt, for low and minimal risk isolation.

Does the whole gown meet the level, seams and back included?

For isolation gowns the whole gown except bindings, cuffs and hems is a critical zone, so seams and back count. Each listing states the critical zone coverage and the seam construction where the manufacturer states them.

Which gowns do we stock for Enhanced Barrier Precautions?

Nursing homes stock gowns at the door of every room on Enhanced Barrier Precautions, for high-contact care. No particular barrier level is mandated, so Level 1 and Level 2 gowns and film gowns with thumb loops carry most of that volume. The stocking guide gives a planning method.

Do we handle chemotherapy drugs?

Oncology and pharmacy buy chemotherapy gowns as a separate item under USP chapter 800. They are tested for resistance to hazardous drugs, with the drugs tested and breakthrough times stated on the quote.

Sizes, closure, cuff and gowns per case?

Gowns come universal, large, XL and 2XL, with ties, hook-and-loop or over-the-head closures and knit, elastic or thumb-loop cuffs. Ten per bag and 50 or 100 per case are typical. Each listing shows the configuration and the count per case.

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.