← Back to catalogue

Medline

FDA UDI

Class I (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
MEDLINE FDA UDI
Generic Name
Surgical/examination garment kit FDA UDI
Device Name
STERILE CUT GLOVES A2 CUT RESISTANT M FDA UDI
Model / Reference
STERCUT2M FDA UDI
Description
STERILE CUT GLOVES A2 CUT RESISTANT M FDA UDI

Identifiers

Catalog Number
STERCUT2M FDA UDI
Primary DI / UDI-DI
10193489196733 FDA UDI
FDA Product Code
LYU FDA UDI
GMDN Term
Surgical/examination garment kit 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical/examination garment kit

Medline by Medline Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical/examination garment kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Sources (1)

  • FDA UDI 6d04c92a-31e6-4848-9edf-bc9e757a5544 35 fields · synced Jun 8, 2026