Identity
- Trade Name
- NEIL MEDICAL FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Disposable Nitrile Powder free Examination Gloves FDA UDI
- Model / Reference
- N100 FDA UDI
- Description
- Disposable Nitrile Powder free Examination Gloves FDA UDI
Identifiers
- Catalog Number
- N100 FDA UDI
- Primary DI / UDI-DI
- 00850063139168 FDA UDI
- FDA Product Code
- LZA 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Neil Medical by Neil Medical Group — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K121526 also covers:
- BASIC — Intco Medical Industries, Inc.
- BASIC — Intco Medical Industries, Inc.
- BASIC — Intco Medical Industries, Inc.
- BASIC — Intco Medical Industries, Inc.
- NEIL MEDICAL — NEIL MEDICAL GROUP
- NEIL MEDICAL — NEIL MEDICAL GROUP
- NEIL MEDICAL — NEIL MEDICAL GROUP
- PEIPU Patient Nitrile Examination Gloves (blue) — shenzhenshishentongdianziyouxiangongsi
- PEIPU Patient Nitrile Examination Gloves (blue) — shenzhenshishentongdianziyouxiangongsi
- PEIPU Patient Nitrile Examination Gloves (blue) — shenzhenshishentongdianziyouxiangongsi
- PEIPU Patient Nitrile Examination Gloves (blue) — shenzhenshishentongdianziyouxiangongsi
- PEIPU Patient Nitrile Examination Gloves blue1 — shenzhenshishentongdianziyouxiangongsi
K210779 also covers:
K231439 also covers:
- ADVANCE IF 36 — Diamond Gloves
- ADVANCE IF 36 — Diamond Gloves
- ADVANCE IF 36 — Diamond Gloves
- ADVANCE IF 36 — Diamond Gloves
- ADVANCE IF 36 — Diamond Gloves
- ADVANCE IF 36 — Diamond Gloves
- ADVANCE IF 42 — Diamond Gloves
- ADVANCE IF 42 — Diamond Gloves
- ADVANCE IF 42 — Diamond Gloves
- ADVANCE IF 42 — Diamond Gloves
- ADVANCE IF 42 — Diamond Gloves
- ADVANCE IF 42 — Diamond Gloves
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
- Neil Medical Group
Sources (1)
- FDA UDI a4b4ef62-8e6b-48a6-98bb-ca355a9126a0 35 fields · synced Jun 6, 2026