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Medical Nitrile Examination Gloves (Power free, Blue)
FDA UDIFDA 510(k)Class I (US FDA UDI)
510(k) K210578
Identity
- Trade Name
- Medical Nitrile Examination Gloves (Power free, Blue) FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- smooth surface, powder free FDA UDI
- Model / Reference
- S FDA UDI
- Description
- smooth surface, powder free FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16920756761967 FDA UDI
- 510(k) Number
- K210578 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Medical Nitrile Examination Gloves (Power free, Blue) by Jiangxi Hongda Medical Equipment Group Co., Ltd. — Class I — FDA_510K — listed in FDA GUDID, FDA 510(k)
Similar devices
Also classified as Nitrile examination/treatment glove, non-powdered, non-antimicrobial.
- VitalGard® Nitrile — Dash Medical Gloves, Inc. · Class I
- Hongray — Grand Work Plastic Products Co., Ltd. · Class I
- Get-A-Grip — SUMMIT GLOVE INC. · Class I
- 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
K210578 also covers:
- Medical Nitrile Examination Gloves (Power free, Blue) — Jiangxi Hongda Medical Equipment Group Co., Ltd.
- Medical Nitrile Examination Gloves (Power free, Blue) — Jiangxi Hongda Medical Equipment Group Co., Ltd.
- Medical Nitrile Examination Gloves (Power free, Blue) — Jiangxi Hongda Medical Equipment Group Co., Ltd.
- Medical Nitrile Examination Gloves (Power free, Blue) — Jiangxi Hongda Medical Equipment Group Co., Ltd.
- Medical Nitrile Examination Gloves (Power free, Blue) — Jiangxi Hongda Medical Equipment Group Co., Ltd.
- Medical Nitrile Examination Gloves (Power free, Blue) — Jiangxi Hongda Medical Equipment Group Co., Ltd.
- Medical Nitrile Examination Gloves (Power free, Blue) — Jiangxi Hongda Medical Equipment Group Co., Ltd.
- Medical Nitrile Examination Gloves (Power free, Blue) — Jiangxi Hongda Medical Equipment Group Co., Ltd.
- Medical Nitrile Examination Gloves (Power free, Blue) — Jiangxi Hongda Medical Equipment Group Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210578 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiangxi Hongda Medical Equipment Group Co., Ltd.
- FDA Applicant
- Jiangxi Hongda Medical Equipment Group , Ltd.
Sources (2)
- FDA UDI 02b6fe80-7a90-4257-93f9-42d9745c6720 58 fields · synced Jun 18, 2026
- FDA 510(k) K210578 1 fields · synced May 29, 2026