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SafeHealth

FDA UDIFDA 510(k)

Class I (US FDA UDI)

510(k) K905055

by Pm Gloves U S A Inc

Identity

Trade Name
SafeHealth FDA UDI
Generic Name
Vinyl examination/treatment glove, non-powdered FDA UDI
Device Name
VINYL EXAMINATION GLOVES, Clear (XL) FDA UDI
Model / Reference
SVF4C5 FDA UDI
Description
VINYL EXAMINATION GLOVES, Clear (XL) FDA UDI

Identifiers

Catalog Number
SVF4C5 FDA UDI
Primary DI / UDI-DI
04712832880649 FDA UDI
FDA Product Code
LYZ FDA UDI
GMDN Term
Vinyl examination/treatment glove, non-powdered FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6250 FDA UDI
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

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Vinyl examination/treatment glove, non-powdered

SafeHealth by Pm Gloves U S A Inc — Class I — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Similar devices

Also classified as Vinyl examination/treatment glove, non-powdered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pm Gloves U S A Inc
FDA Applicant
Pm Gloves, Inc.

Sources (2)

  • FDA UDI e35d6ccb-3d1a-400f-9c17-67887222ca9b 60 fields · synced Jun 19, 2026
  • FDA 510(k) K905055 1 fields · synced May 22, 2026