Dynarex Next Generation Stretch Vinyl Exam Glove100/box · 10 boxes/case
Dynarex Corporation · Next Generation Stretch Vinyl
- Intended use: patient examination
- Not made with natural rubber latex
- Powder-free
Image: Dynarex Corporation- Manufacturer
- Dynarex Corporation
- Brand or line
- Next Generation Stretch Vinyl
- Country of manufacture
- China (per manufacturer document; subject to change)
- FDA 510(k)
- K100486 View FDA’s record (opens fda.gov)
- Product code
- LYZ
- Intended use
- A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner
- Latex
- Not made with natural rubber latex (manufacturer statement)
- Powder
- Powder-free
- Manufacturer page
- dynarex.com
Specifications
- Fingertip 3.0 mil (0.08 mm)
- Palm 3.0 mil (0.08 mm)
| Attribute | Value | Basis |
|---|---|---|
| Thickness, weight and length | ||
| Thickness — fingertip (point 1 on the drawing) | 3.0 mil (0.08 mm) Minimum · Manufacturer spec | Minimum · Manufacturer spec |
| Thickness — palm (point 2 on the drawing) | 3.0 mil (0.08 mm) Minimum · Manufacturer spec | Minimum · Manufacturer spec |
| Weight per glove | Not stated by the manufacturer | |
| Length | 9 in (229 mm) Nominal · Manufacturer spec | Nominal · Manufacturer spec |
| Quality and strength | ||
| Pinhole AQL | 2.5 510(k) acceptance criterion, inspection level I · FDA minimum for exam gloves: 2.5 | 510(k) acceptance criterion, inspection level I · FDA minimum for exam gloves: 2.5 |
| Tensile strength | Not stated by the manufacturer | |
| Elongation | Not stated by the manufacturer | |
| Standards stated by the manufacturer | Not stated by the manufacturer | |
| Construction | ||
| Texture | Not stated by the manufacturer | |
| Cuff | Beaded | |
| Color | Same color as latex | |
| Sterility | Not stated by the manufacturer | |
| Testing | ||
| Chemotherapy testing | Not stated by the manufacturer | |
| Fentanyl testing | Not stated by the manufacturer | |
| Storage | ||
| Shelf life | Not stated by the manufacturer — confirmed on your quote | |
| Storage | Not stated by the manufacturer | |
Packaging
Pack-out by size.
Scroll sideways to see all columns. The size stays in view.
| Size | Mfr item no. | Gloves per box | Boxes per case | Gloves per case |
|---|---|---|---|---|
| S | 6822 | 100 | 10 | 1,000 |
| M | 6823 | 100 | 10 | 1,000 |
| L | 6824 | 100 | 10 | 1,000 |
| XL | 6825 | 100 | 10 | 1,000 |
- Cases per pallet
- We’ll confirm pallet configuration on your quote.
Mixed sizes in one case: not available · Mixed sizes in one order: yes.
Documents
Documents we may share publicly, plus FDA’s own record
-
Verify on FDA’s database (opens fda.gov) 510(k) summary K100486, Patient Vinyl Examination Gloves, Powder Free, Non-Sterile, Yellow Color
510(k) summary K100486, Patient Vinyl Examination Gloves, Powder Free, Non-Sterile, Yellow Color · FDA
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Verify on FDA’s database (opens fda.gov) FDA 510(k) record K100486
FDA database record — FDA 510(k) record K100486
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View the brand owner’s copy (opens dynarex.com) Dynarex Next Generation Stretch Vinyl Exam Gloves product page (item 6824, specification table)
Dynarex Next Generation Stretch Vinyl Exam Gloves product page (item 6824, specification table) · Brand owner’s site
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View the brand owner’s copy (opens pimassetsprod01.blob.core.windows.net) Dynarex Next Generation Stretch Vinyl Exam Gloves sell sheet (6822-6825)
Brochure · Brand owner’s site — Dynarex Next Generation Stretch Vinyl Exam Gloves sell sheet (6822-6825)
-
Lot certificate of analysis
Any other document is available from your representative on request.
Testing and claims
As stated by the manufacturer, in the manufacturer’s scope — with the document each statement comes from.
- Fda 510k
- Manufacturer's FDA 510(k): K100486 - patient examination glove (21 CFR 880.6250). Per the FDA record (FDA database record)
- Latex statement
- Not made with natural rubber latex. Per the manufacturer's product page
- Powder
- Powder-free. Per the manufacturer's brochure
- Thickness
- Finger and palm 3 mil minimum, per manufacturer (Dynarex product page). Per the manufacturer's product page
How to read this page
Every value on this page is the manufacturer’s own statement or a regulator’s record, with the document named. Where a manufacturer does not state a value, the page says so. Pricing, availability and lead time are confirmed on your written quote.