← Back to catalogue
Standard Surgical Gown (AAMI Level 3)
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref CH-0157Model CH-0154、CH-0156、CH-0157、CH-0158、CH-0159、CH-0162、CH-0156X、CH-0157X、CH-0158X、CH-0159X、T0299
Identity
- Trade Name
- Standard Surgical Gown (AAMI Level 3) FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- Disposable Suit EUDAMED
- Model / Reference
- CH-0154、CH-0156、CH-0157、CH-0158、CH-0159、CH-0162、CH-0156X、CH-0157X、CH-0158X、CH-0159X、T0299 EUDAMEDCH-0157 EUDAMEDPM5011SGN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973062320208 EUDAMEDFDA UDI
- Basic UDI-DI
- 697306232SUITNQ EUDAMED
- 510(k) Number
- K210143 FDA UDI
- FDA Product Code
- FYA FDA UDI
- EMDN Code
- T020499 SURGICAL GOWNS - OTHER EUDAMED
- GMDN Term
- Surgical gown, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Ethylene Oxide FDA UDI
Category: Surgical gown, single-use
Standard Surgical Gown (AAMI Level 3) by Foshan Nanhai Plus Medical Co., Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Surgical gown, single-use.
- Halyard — O&M HALYARD, INC. · Class II
- Yellow gown with elastics (length 120 cm) — Omnia Spa · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- Beaver Visitec Inter — GRI Medical & Electronic Technology Co., Ltd. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- T7 — Stryker Corp. · Class II
- StringKing — String King Lacrosse, LLC · Class II
Cleared under the same submission
K210143 also covers:
- Reinforce Surgical Gown (AAMI Level 3) — Foshan Nanhai Plus Medical Co., Ltd
- Reinforce Surgical Gown (AAMI Level 3) — Foshan Nanhai Plus Medical Co., Ltd
- Reinforce Surgical Gown (AAMI Level 3) — Foshan Nanhai Plus Medical Co., Ltd
- Reinforce Surgical Gown (AAMI Level 3) — Foshan Nanhai Plus Medical Co., Ltd
- Reinforce Surgical Gown (AAMI Level 3) — Foshan Nanhai Plus Medical Co., Ltd
- Reinforce Surgical Gown (AAMI Level 3) — Foshan Nanhai Plus Medical Co., Ltd
- Reinforce Surgical Gown (AAMI Level 3) — Foshan Nanhai Plus Medical Co., Ltd
- Reinforce Surgical Gown (AAMI Level 3) — Foshan Nanhai Plus Medical Co., Ltd
- Reinforce Surgical Gown (AAMI Level 3) — Foshan Nanhai Plus Medical Co., Ltd
- Reinforce Surgical Gown (AAMI Level 3) — Foshan Nanhai Plus Medical Co., Ltd
- Reinforce Surgical Gown (AAMI Level 3) — Foshan Nanhai Plus Medical Co., Ltd
- Reinforce Surgical Gown (AAMI Level 3) — Foshan Nanhai Plus Medical Co., Ltd
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Foshan Nanhai Plus Medical Co., Ltd
Sources (2)
- FDA UDI d50dca1c-e5e9-416b-9d25-91c4996025d9 33 fields · synced Aug 1, 2026
- EUDAMED d2875b59-5c4c-4b20-a096-192339b72037 61 fields · synced Aug 1, 2026