customized L
by Qingdao Bestex Rubber & Plastic Products Co., Ltd. 2 variants
customized L is a Class I device made by Qingdao Bestex Rubber & Plastic Products Co., Ltd., listed in FDA GUDID since 16 Jun 2023 (UDI-DI 16921340883119), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number16921340883119 | Date16 Jun 2023 | StatusListed |
Official records
- AccessGUDID record 16921340883119
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- customized
- Generic name
- Isolation gown, single-use
- Model / reference
- L
- Primary DI / UDI-DI
- 16921340883119
- FDA product code
- FXO
- GMDN term
- Isolation gown, single-use
- Device class
- Class I
- Regulation number
- 878.4040
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code FXO (Suit, Surgical).
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- SPUNGUARD SCRUB SUIT by KIMBERLY-CLARK CORPORATION
- SURGICAL GARMENTS by Ulti-Med Intl., Inc.
- BTP(TM) CENTRALINE(TM) SUIT by Btp Industries, Inc.
- APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE by Pro-Safe Professional Linens, Inc.
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