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Plus Medical Isolation Gown Level 3

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K212698

by Foshan Nanhai Plus Medical Co., Ltd

Identity

Trade Name
Plus Medical Isolation Gown Level 3 FDA UDI
Generic Name
Isolation gown, single-use FDA UDI
Model / Reference
PM4401FG FDA UDI

Identifiers

Primary DI / UDI-DI
06973062321281 FDA UDI
510(k) Number
K212698 FDA 510(k)FDA UDI
FDA Product Code
FYC FDA 510(k)FDA UDI
GMDN Term
Isolation gown, single-use FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 878.4040 FDA 510(k)
Regulation Number
878.4040 FDA 510(k)FDA UDI
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Plus Medical Isolation Gown Level 3 by Foshan Nanhai Plus Medical Co., Ltd — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Foshan Nanhai Plus Medical Co., Ltd
FDA Applicant
Foshan Nanhai Plus Medical Co, Ltd.

Sources (2)

  • FDA 510(k) K212698 24 fields · synced Jun 18, 2026
  • FDA UDI b4d0d658-7861-49e9-967c-7e51334feeb0 33 fields · synced May 27, 2026