AMERICAN PROTECTIVE PRODUCTS

GUDID 10850063938201

American Protective Products LLC

Surgical/examination garment kit

• Primary Device ID: 10850063938201
• NIH Device Record Key: 645f9f5a-ccb7-44ce-bf52-5ff3ac36168c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMERICAN PROTECTIVE PRODUCTS
• Version Model Number: G-N502-BL-SM
• Company DUNS: 117079262
• Company Name: American Protective Products 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10850063938201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152720

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: 2024-07-08
• Device Publish Date: 2024-06-30

On-Brand Devices [AMERICAN PROTECTIVE PRODUCTS]

• 10850063938249: G-N506-BL-2X
• 10850063938232: G-N505-BL-XL
• 10850063938225: G-N504-BL-LG
• 10850063938218: G-N503-BL-MD
• 10850063938201: G-N502-BL-SM
• 10850063938195: G-N501-BL-XS
• 10850063938188: G-N606-BK-2X
• 10850063938171: G-N605-BK-XL
• 10850063938164: G-N604-BK-LG
• 10850063938157: G-N603-BK-MD
• 10850063938140: G-N602-BK-SM
• 10850063938133: G-N601-BK-XS
• 10850063938126: G-N406-BK-2X
• 10850063938119: G-N405-BK-XL
• 10850063938102: G-N404-BK-LG
• 10850063938096: G-N403-BK-MD
• 10850063938089: G-N402-BK-SM
• 10850063938072: G-N401-BK-XS
• 10850063938065: G-N306-VI-2X
• 10850063938058: G-N305-VI-XL
• 10850063938041: G-N304-VI-LG
• 10850063938034: G-N303-VI-MD
• 10850063938027: G-N302-VI-SM
• 10850063938010: G-N301-VI-XS
• 10850063932612: G-N506-BL-2X-M
• 10850063932605: G-N505-BL-XL-M
• 10850063932599: G-N504-BL-LG-M
• 10850063932582: G-N503-BL-MD-M
• 10850063932575: G-N502-BL-SM-M
• 10850063932568: G-N501-BL-XS-M