Identity
- Trade Name
- Chongjen FDA UDI
- Generic Name
- Assistive glove/mitten FDA UDI
- Model / Reference
- HDPE Gloves,L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974681690581 FDA UDI
- FDA Product Code
- LYU FDA UDI
- GMDN Term
- Assistive glove/mitten FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4040 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Assistive glove/mitten
Chongjen by Shanghai Chongjen Industry Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Assistive glove/mitten.
- Vive — VIVE HEALTH LLC · Class I
- Chongjen — SHANGHAI CHONGJEN INDUSTRY CO., LTD. · Class I
- Chongjen — SHANGHAI CHONGJEN INDUSTRY CO., LTD. · Class I
- Chongjen — SHANGHAI CHONGJEN INDUSTRY CO., LTD. · Class I
- Chongjen — SHANGHAI CHONGJEN INDUSTRY CO., LTD. · Class I
- Chongjen — SHANGHAI CHONGJEN INDUSTRY CO., LTD. · Class I
- Chongjen — SHANGHAI CHONGJEN INDUSTRY CO., LTD. · Class I
- Chongjen — SHANGHAI CHONGJEN INDUSTRY CO., LTD. · Class I
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
- Shanghai Chongjen Industry Co., Ltd.
Sources (1)
- FDA UDI e8499fbc-40ca-4e3a-acff-2fe0b9a0d07d 32 fields · synced May 31, 2026