Identity
- Trade Name
- BEASTEK FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Model / Reference
- BTN1442 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810160180005 FDA UDI
- 510(k) Number
- K203593 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Beastek by Supmedics Inc. — 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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- MARK3 — CARGUS INTERNATIONAL, INC · Class I
- NitriSkin XP — Medgluv Inc. · Class I
- First Aid Only — Acme United Corporation · Class I
- FINISHMASTER — Bunzl USA Holdings LLC · Class I
- Medicom AssureTouch — AMD Medicom Inc · Class I
Cleared under the same submission
K203593 also covers:
- AURA — Guangdong KINGFA SCI.&TECH. Co., Ltd.
- AURA — Guangdong KINGFA SCI.&TECH. Co., Ltd.
- AURA — Guangdong KINGFA SCI.&TECH. Co., Ltd.
- AURA — Guangdong KINGFA SCI.&TECH. Co., Ltd.
- KINGFA MEDICAL — Guangdong KINGFA SCI.&TECH. Co., Ltd.
- KINGFA MEDICAL — Guangdong KINGFA SCI.&TECH. Co., Ltd.
- KINGFA MEDICAL — Guangdong KINGFA SCI.&TECH. Co., Ltd.
- KINGFA MEDICAL — Guangdong KINGFA SCI.&TECH. Co., Ltd.
- KINGFA MEDICAL — Guangdong KINGFA SCI.&TECH. Co., Ltd.
- KINGFA MEDICAL — Guangdong KINGFA SCI.&TECH. Co., Ltd.
- KINGFA MEDICAL — Guangdong KINGFA SCI.&TECH. Co., Ltd.
- KINGFA MEDICAL — Guangdong KINGFA SCI.&TECH. Co., Ltd.
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
- Supmedics Inc.
Sources (1)
- FDA UDI d7514aea-9d43-49c9-a99f-93c9722f0405 33 fields · synced Jun 8, 2026