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The Safety Zone

FDA UDI

Class I (US FDA UDI)

by Impact Products, Llc

Identity

Trade Name
The Safety Zone FDA UDI
Generic Name
Hevea-latex surgical glove, non-powdered, non-antimicrobial FDA UDI
Device Name
Medium Latex Powder Free Exam Glove FDA UDI
Model / Reference
GREP-MD-1 FDA UDI
Description
Medium Latex Powder Free Exam Glove FDA UDI

Identifiers

Catalog Number
GREP-MD-1 FDA UDI
Primary DI / UDI-DI
B340GREPMD1 FDA UDI
510(k) Number
K022016 FDA UDI
FDA Product Code
LYY FDA UDI
GMDN Term
Hevea-latex surgical glove, non-powdered, non-antimicrobial 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

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

No

FDA UDI

Category: Hevea-latex surgical glove, non-powdered, non-antimicrobial

The Safety Zone by Impact Products, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hevea-latex surgical glove, non-powdered, non-antimicrobial.

Cleared under the same submission

K022016 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Impact Products, Llc

Sources (1)

  • FDA UDI 244cb1b9-f21c-4e54-9f43-8bc151840e51 35 fields · synced Jun 1, 2026