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Reflection Sapphire Sensitive Nitrile Pf Exam Med

FDA UDI

Class I (US FDA UDI)

by Smart Health Llc

Identity

Trade Name
REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM MED FDA UDI
Generic Name
Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Device Name
GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM MED*200 FDA UDI
Model / Reference
431108 FDA UDI
Description
GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM MED*200 FDA UDI

Identifiers

Catalog Number
431108 FDA UDI
Primary DI / UDI-DI
D7664311081 FDA UDI
FDA Product Code
LZA FDA UDI
LZC FDA UDI
QDO FDA UDI
GMDN Term
Nitrile examination/treatment 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

Yes

FDA UDI

Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Reflection Sapphire Sensitive Nitrile Pf Exam Med by Smart Health Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smart Health Llc

Sources (1)

  • FDA UDI 167852b3-ca2e-45fe-81de-348b8abd6444 37 fields · synced May 31, 2026