Identity
- Trade Name
- DermaThin FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- SHOWA, DermaThin® Nitrile PF Exam Biodegradable with Eco Best Technology® (EBT), Chemo claim, fingertip textured, Blue, XXL FDA UDI
- Model / Reference
- XXL FDA UDI
- Description
- SHOWA, DermaThin® Nitrile PF Exam Biodegradable with Eco Best Technology® (EBT), Chemo claim, fingertip textured, Blue, XXL FDA UDI
Identifiers
- Catalog Number
- M7002PFXXL FDA UDI
- Primary DI / UDI-DI
- 00038054654313 FDA UDI
- 510(k) Number
- K211003 FDA UDI
- FDA Product Code
- LZA FDA UDILZC 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
DermaThin by Showa Best Glove, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K211003 also covers:
- DermaThin — Showa Best Glove, Inc.
- DermaThin — Showa Best Glove, Inc.
- DermaThin — Showa Best Glove, Inc.
- DermaThin — Showa Best Glove, Inc.
- DermaThin — Showa Best Glove, Inc.
- N-Dex — Showa Best Glove, Inc.
- N-Dex — Showa Best Glove, Inc.
- N-Dex — Showa Best Glove, Inc.
- N-Dex — Showa Best Glove, Inc.
- N-Dex — Showa Best Glove, Inc.
- N-Dex — Showa Best Glove, Inc.
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 |
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Manufacturer
- Manufacturer
- Showa Best Glove, Inc.
Sources (1)
- FDA UDI aaaa1e04-7d7a-4b2c-bbd6-069d66d7998a 36 fields · synced May 31, 2026