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GTDI item EX-1301

Latex exam glove, 5.1 mil, light green, textured

  • FDA 510(k) cleared
  • ASTM D3578
  • Powder-free

Powder-free natural rubber latex patient examination glove, non-sterile, fully textured, with a lanolin and vitamin E inner coating as stated by the manufacturer. Thickness 4.3 to 5.1 mil as stated, with no measuring point given; manufacturer-stated pinhole AQL 1.5; meets ASTM D3578 as stated. Caution: this product contains natural rubber latex, which may cause allergic reactions. 100 gloves per box, 10 boxes per case.

100 per box, 10 boxes Gloves
Render of a box of latex exam gloves with one light green latex glove
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 EX-1301 Internal
Product type Patient examination glove FDA intended-use definitions
Regulatory status Patient examination glove, FDA Class I medical device (21 CFR 880.6250), 510(k) cleared. The 510(k) number is stated on your quote. The product's own clearance or absence of one
FDA product code LYY FDA product classification database
Material and construction
Material Natural rubber latex with a lanolin and vitamin E inner coating, as stated by the manufacturer Manufacturer specification
Powder Powder-free Manufacturer specification
Sizes offered XS, S, M, L, XL Manufacturer specification
Texture Fully textured Manufacturer specification
Color Light green Manufacturer specification
Thickness and length
Thickness, single wall (no measuring point given by the manufacturer) 4.3 to 5.1 mil Manufacturer specification
Performance, testing and labeling
Pinhole AQL 1.5 (no inspection level given). FDA's maximum for exam gloves is 2.5 Manufacturer specification
Natural rubber latex Contains natural rubber latex FDA labeling guidance
Latex caution Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. 21 CFR 801.437
Sterility Non-sterile Manufacturer specification
Standards stated by the manufacturer ASTM D3578 Manufacturer statement
Storage, origin and packaging
Country of origin Confirmed on quote Confirmed on quote
Packaging 100 gloves per box, 10 boxes per case Manufacturer specification

Sizes and packaging

Pack-out by sizeEach case holds one size. Mixed sizes ship as separate case lines.
Size Variant code Gloves per box Boxes per case Gloves per case
XS EX-1301-XS 100 10 1,000
S EX-1301-S 100 10 1,000
M EX-1301-M 100 10 1,000
L EX-1301-L 100 10 1,000
XL EX-1301-XL 100 10 1,000

Standards, testing and claims

FDA 510(k) cleared
Patient examination glove, FDA Class I medical device (21 CFR 880.6250), 510(k) cleared. The 510(k) number is stated on your quote.Basis: FDA 510(k) record; the number is stated on your quote
ASTM D3578
Powder-free
Basis: Manufacturer specification
Pinhole AQL
Pinhole AQL 1.5, stated by the manufacturer (inspection level not given). FDA's maximum for exam gloves is 2.5.Basis: As stated by the manufacturer; the document is supplied with the quote

Patient examination glove, FDA Class I medical device (21 CFR 880.6250), 510(k) cleared. The 510(k) number is stated on your quote.

Provided with your quote

  • FDA 510(k) summary 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

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

Questions buyers ask about exam gloves

  • Every latex glove page carries the caution: "This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."
  • Nitrile and vinyl exam gloves are listed separately as the alternative for staff who react.
  • Protein content in micrograms per square decimeter is stated where the manufacturer publishes it.
Is this glove cleared for patient care, or is it an industrial glove?

Every glove in this group is a patient examination glove with an FDA 510(k) clearance, and the K number is on your quote so you can check it in the FDA database. Industrial and food-service gloves are not medical devices and are listed in their own group.

Which material, and does anyone have a latex allergy?

Nitrile is the default synthetic, with good puncture and chemical resistance. Latex has the highest stretch and tactile feel, and every latex device carries FDA's required caution about allergic reactions. Vinyl is the lowest-cost option with a looser fit. Nitrile and vinyl gloves are not made with natural rubber latex, and OSHA requires an alternative glove for staff who are allergic to the glove normally provided.

How thick is it, and measured where?

Thickness is stated in mil at the fingertip, the palm and sometimes the cuff. The fingertip is usually the thickest point and the figure makers lead with, so compare fingertip with fingertip. The nitrile specification sets a minimum of only 0.05 mm, about 2 mil, so a 3 mil glove and a 6 mil glove both meet it. Thickness is a product choice, not a grade.

What does an AQL of 1.5 against 2.5 mean in practice?

AQL is a sampling plan setting for pinholes, not a defect rate for the box in your hand. FDA's minimum for exam gloves is 2.5. Many makers state 1.5 or 1.0 for their own production. Read the figure with its inspection level, and ask for a certificate of analysis for the lot you receive.

Do we handle chemotherapy drugs or fentanyl, and what was this glove tested against?

A chemo-tested glove has been tested for permeation by specific drugs under ASTM D6978, with a breakthrough time for each drug. The claim covers only the drugs on the manufacturer's list, and some lists carry cautions against two drugs. Fentanyl testing is a separate claim with its own FDA product code. The tested drug list comes with your quote.

Which sizes, and how many gloves per box in each size?

Sizes run XS to XXL by palm width. One hundred per box is common, but light gloves come 200 to 300 per box and extended-cuff gloves 50, and large sizes often hold fewer. Each case holds one size. Every listing shows gloves per box for every size and boxes per case, and every quote shows the price per case and per 1,000 gloves.

Where is it made, and what does that mean for price and lead time?

Most exam gloves are made in Southeast Asia, and duty differs by country of origin. Every product page shows the country of origin where it is stable, and every quote confirms it with the lead time and the valid-until date, so you can hold a price for the period stated.

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.