Identity
- Trade Name
- DEFENDER FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Nitrile disposable 4 mil powder-free examination glove, 100 gloves per box. Medical Grade, Chemotherapy drug tested, Not made with Rubber Latex, Low Derma, Protection against Fentanyl, Single use, Non-sterile. Size is X-large. FDA UDI
- Model / Reference
- AMSDEF4-XL FDA UDI
- Description
- Nitrile disposable 4 mil powder-free examination glove, 100 gloves per box. Medical Grade, Chemotherapy drug tested, Not made with Rubber Latex, Low Derma, Protection against Fentanyl, Single use, Non-sterile. Size is X-large. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850031575042 FDA UDI
- 510(k) Number
- K181857 FDA UDI
- FDA Product Code
- LZA FDA UDILZC FDA UDIQDO FDA UDI
- GMDN Term
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Defender by Armstrong Medical Supply, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nitrile examination/treatment glove, non-powdered, non-antimicrobial.
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- NitriSkin XP — Medgluv Inc. · Class I
- First Aid Only — Acme United Corporation · Class I
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- Medicom AssureTouch — AMD Medicom Inc · Class I
Cleared under the same submission
K181857 also covers:
- DEFENDER — Armstrong Medical Supply, LLC
- DEFENDER — Armstrong Medical Supply, LLC
- DEFENDER — Armstrong Medical Supply, LLC
- DEFENDER — Armstrong Medical Supply, LLC
- DEFENDER — Armstrong Medical Supply, LLC
- DEFENDER MAX — Armstrong Medical Supply, LLC
- DEFENDER MAX — Armstrong Medical Supply, LLC
- DEFENDER MAX — Armstrong Medical Supply, LLC
- DEFENDER MAX — Armstrong Medical Supply, LLC
- DEFENDER MAX — Armstrong Medical Supply, LLC
- DEFENDER MAX — Armstrong Medical Supply, LLC
- DEFENDER PLUS — Armstrong Medical Supply, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Armstrong Medical Supply, LLC
Sources (1)
- FDA UDI 36124eb3-519d-43d4-99d2-ceed74d02f14 36 fields · synced May 31, 2026