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

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

• Primary Device ID: 00711583360954
• NIH Device Record Key: 9fc02495-39a9-44bd-a1ec-a294d84830ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LYDUS Nitrile Examination Gloves, Powder Free
• Version Model Number: FRSNS-LYDUSNTRL
• Company DUNS: 080344373
• Company Name: The Stronghold Group LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00711583360954 [Package]; Contains: 00711583361104; Package: Carton [10 Units]; In Commercial Distribution
GS1	00711583361104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203191

FDA Product Code

• LZA: Polymer Patient Examination Glove

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-07
• Device Publish Date: 2022-02-27

Devices Manufactured by The Stronghold Group LLC

• 10850037694645 - Stronghold PP/PE Isolation Gown (AAMI Level 2)-S: 2022-03-28 This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids
• 00850037694693 - Stronghold PP/PE Isolation Gown (AAMI Level 2)-M: 2022-03-28 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)-L: 2022-03-28 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)-XL: 2022-03-28 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)-Unisize: 2022-03-28 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)-S: 2022-03-28 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)-M: 2022-03-28 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)-L: 2022-03-28 This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids