LYDUS Nitrile Examination Gloves, Powder Free

GUDID 00711583360954

Patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. See product packaging for size identification. Carton of 100 pieces/inner box.

The Stronghold Group LLC

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Primary Device ID00711583360954
NIH Device Record Key9fc02495-39a9-44bd-a1ec-a294d84830ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameLYDUS Nitrile Examination Gloves, Powder Free
Version Model NumberFRSNS-LYDUSNTRL
Company DUNS080344373
Company NameThe Stronghold Group LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100711583360954 [Package]
Contains: 00711583361104
Package: Carton [10 Units]
In Commercial Distribution
GS100711583361104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZAPolymer Patient Examination Glove

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-07
Device Publish Date2022-02-27

Devices Manufactured by The Stronghold Group LLC

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00850037694693 - Stronghold PP/PE Isolation Gown (AAMI Level 2)-M2022-03-28 This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids
00850037694709 - Stronghold PP/PE Isolation Gown (AAMI Level 2)-L2022-03-28 This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids
00850037694716 - Stronghold PP/PE Isolation Gown (AAMI Level 2)-XL2022-03-28 This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids
00850037694723 - Stronghold PP/PE Isolation Gown (AAMI Level 2)-Unisize2022-03-28 This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids
00850037694785 - Stronghold SMS Isolation Gown (AAMI Level 2)-S2022-03-28 This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids
00850037694792 - Stronghold SMS Isolation Gown (AAMI Level 2)-M2022-03-28 This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids
00850037694808 - Stronghold SMS Isolation Gown (AAMI Level 2)-L2022-03-28 This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids
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