GTDI item EX-1108
Nitrile exam glove, 3.5 mil, light blue, 300 per box
- ASTM D6319
- Powder-free
- Not made with natural rubber latex
Powder-free light blue nitrile patient examination glove, non-sterile, with textured fingertips. Thickness 2.7 to 3.5 mil as stated by the manufacturer, which gives no measuring point; manufacturer-stated pinhole AQL 1.5; meets ASTM D6319 as stated. 300 gloves per box (250 in XL), 10 boxes per case.
Specifications
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| Attribute | Value | Basis |
|---|---|---|
| Identity and regulatory status | ||
| GTDI item code | EX-1108 | Internal |
| Product type | Patient examination glove | FDA intended-use definitions |
| Regulatory status | Patient examination glove, FDA Class I medical device (21 CFR 880.6250). The 510(k) number is confirmed on your quote. | The product's own clearance or absence of one |
| Material and construction | ||
| Material | Nitrile | Manufacturer specification |
| Powder | Powder-free | Manufacturer specification |
| Sizes offered | XS, S, M, L, XL | Manufacturer specification |
| Texture | Textured fingertips | Manufacturer specification |
| Color | Light blue | Manufacturer specification |
| Thickness and length | ||
| Thickness, single wall (no measuring point given by the manufacturer) | 2.7 to 3.5 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 | Not made with natural rubber latex | FDA labeling guidance |
| Sterility | Non-sterile | Manufacturer specification |
| Standards stated by the manufacturer | ASTM D6319 | Manufacturer statement |
| Storage, origin and packaging | ||
| Country of origin | Confirmed on quote | Confirmed on quote |
| Packaging | 300 gloves per box (250 in XL), 10 boxes per case | Manufacturer specification |
Sizes and packaging
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| Size | Variant code | Gloves per box | Boxes per case | Gloves per case |
|---|---|---|---|---|
| XS | EX-1108-XS | 300 | 10 | 3,000 |
| S | EX-1108-S | 300 | 10 | 3,000 |
| M | EX-1108-M | 300 | 10 | 3,000 |
| L | EX-1108-L | 300 | 10 | 3,000 |
| XL Differs | EX-1108-XL | 250 | 10 | 2,500 |
Standards, testing and claims
- ASTM D6319
- Powder-free
- Powder-free.Basis: Manufacturer specification
- Not made with natural rubber latex
- Basis: Manufacturer labeling; FDA labeling guidance
- 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). The 510(k) number is confirmed on your quote.
Provided with your quote
- FDA 510(k) letter 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.
Compare with other nitrile exam gloves
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| Product | Fingertip | Palm | AQL | Length | Color | Chemo-tested | Per box |
|---|---|---|---|---|---|---|---|
| Nitrile exam glove, 3.5 mil, light blueGTDI item EX-1108, this page | 2.7 to 3.5 mil | 1.5 | Light blue | 300 or 250 | |||
| Chemo-tested nitrile exam glove, 5.9 milGTDI item EX-1101 | 5.9 mil (0.15 mm) | 4.7 mil (0.12 mm) | 2.5 | 9.5 in (241 mm) | Violet | Yes, ASTM D6978 | 100 or 90 |
| Extended-cuff nitrile exam glove, 12 inGTDI item EX-1102 | 5.9 mil (0.15 mm) | 4.7 mil (0.12 mm) | 2.5 | 12 in (305 mm) | Violet | Yes, ASTM D6978 | 50 |
| Nitrile exam glove, 3.1 mil, 250 per boxGTDI item EX-1103 | 3.1 mil (0.08 mm) | 2.8 mil (0.07 mm) | 1.0 | 9.5 in (241 mm) | Light violet | Yes, ASTM D6978 | 250 or 230 |
| Nitrile exam glove, 4.7 mil, grayGTDI item EX-1104 | 4.7 mil (0.12 mm) | 3.1 mil (0.08 mm) | 1.0 | 9.5 in (241 mm) | Gray | Yes, ASTM D6978 | 200 or 170 |
| Extended-cuff nitrile exam glove, 12 in, grayGTDI item EX-1105 | 4.7 mil (0.12 mm) | 3.5 mil (0.09 mm) | 12 in (305 mm) | Gray | Yes, ASTM D6978 | 100 | |
| Nitrile exam glove, 5.5 mil, two-toneGTDI item EX-1106 | 5.5 mil (0.14 mm) | 3.9 mil (0.1 mm) | 1.0 | Average 242 mm (9.5 in) | Two-tone black and orange | 150 or 140 | |
| Nitrile exam glove, 3.2 mil, blueGTDI item EX-1107 | 2.4 to 3.2 mil | 1.5 | Blue | 300 or 250 | |||
| Nitrile exam glove, 4.5 mil, blackGTDI item EX-1109 | 4.5 mil (0.11 mm) | Minimum 230 mm (9.1 in) | Black | 100 | |||
| Nitrile exam glove, 5.5 mil, blackGTDI item EX-1110 | 5.5 mil (0.14 mm) | Black | 100 or 90 | ||||
| Nitrile exam glove, 6.5 mil, blackGTDI item EX-1111 | 6.5 mil (0.17 mm) | Black | 100 or 90 |
Questions buyers ask about exam gloves
- Compare thickness at the same measuring point. The fingertip is usually the thickest.
- Light gloves of under 3 mil come 200 to 300 per box and suit frequent changes. Heavy gloves of 5 to 7 mil come 50 to 100 per box and suit hazardous drug handling.
- Color is a specification row. It never decides a glove's grade.
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.
Related products
More sub-categories in exam gloves.
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