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Promax OR Gowns

FDA UDI

Class II (US FDA UDI)

by Standard Textile Co., Inc.

Identity

Trade Name
Promax OR Gowns FDA UDI
Generic Name
Surgical gown, reusable FDA UDI
Device Name
OR GWN PROMAX KAUM AQUA 2XL - RM (98 6749) USE: 7567P313 FDA UDI
Model / Reference
7567E943 FDA UDI
Description
OR GWN PROMAX KAUM AQUA 2XL - RM (98 6749) USE: 7567P313 FDA UDI

Identifiers

Catalog Number
7567E943 FDA UDI
Primary DI / UDI-DI
00634916141801 FDA UDI
510(k) Number
K041540 FDA UDI
FDA Product Code
FYA FDA UDI
GMDN Term
Surgical gown, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4040 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Promax OR Gowns by Standard Textile Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K041540 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Standard Textile Co., Inc.

Sources (1)

  • FDA UDI 1a1e1df5-402c-4c03-8e2c-cf4565eb8956 37 fields · synced Jun 8, 2026