Gen-X®

GUDID 19551005270205

Latex Examination Gloves, Powder Free Blue - XS

SMART GLOVE INTERNATIONAL PTE. LTD.

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 19551005270205
• NIH Device Record Key: 0c32d39a-d1bb-4b47-93d2-e6431e70a748
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gen-X®
• Version Model Number: LPFEMD
• Company DUNS: 659506974
• Company Name: SMART GLOVE INTERNATIONAL PTE. LTD.
• Device Count: 100
• 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: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• 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	09551005270208 [Primary]
GS1	19551005270205 [Package]; Contains: 09551005270208; Package: carton [10 Units]; In Commercial Distribution
GS1	29551005270202 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974870

FDA Product Code

• LYY: Latex 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: 2023-11-08
• Device Publish Date: 2023-10-31

On-Brand Devices [Gen-X®]

• 09551005270000: GENPF
• 19551005270052: Nitrile Examination Gloves Powder Free Chemo Tested Blue- XXL
• 19551005270045: Nitrile Examination Gloves Powder Free Chemo Tested Blue- XL
• 19551005270038: Nitrile Examination Gloves Powder Free Chemo Tested Blue- L
• 29551005270028: Nitrile Examination Gloves Powder Free Chemo Tested Blue- M
• 19551005270014: Nitrile Examination Gloves Powder Free Chemo Tested Blue- S
• 19551005270700: Polychloroprene C-series Examination Gloves, Powder Free - XXL
• 19551005270694: Polychloroprene C-series Examination Gloves, Powder Free - XL
• 19551005270687: Polychloroprene C-series Examination Gloves, Powder Free - L
• 19551005270670: Polychloroprene C-series Examination Gloves, Powder Free - M
• 19551005270663: Polychloroprene C-series Examination Gloves, Powder Free - S
• 19551005270656: Polychloroprene C-series Examination Gloves, Powder Free - XS
• 19551005270649: Polychloroprene C-series Examination Gloves, Powder Free - XXS
• 19551005270601: EC Nitrile Examination Gloves, Powder Free (Chemotherapy Drugs Tested and Fentanyl Protection) B
• 19551005270595: EC Nitrile Examination Gloves, Powder Free (Chemotherapy Drugs Tested and Fentanyl Protection) B
• 19551005270588: EC Nitrile Examination Gloves, Powder Free (Chemotherapy Drugs Tested and Fentanyl Protection) B
• 19551005270571: EC Nitrile Examination Gloves, Powder Free (Chemotherapy Drugs Tested and Fentanyl Protection) B
• 19551005270564: EC Nitrile Examination Gloves, Powder Free (Chemotherapy Drugs Tested and Fentanyl Protection) B
• 19551005270557: EC Nitrile Examination Gloves, Powder Free (Chemotherapy Drugs Tested and Fentanyl Protection) B
• 19551005270540: EC Nitrile Examination Gloves, Powder Free (Chemotherapy Drugs Tested and Fentanyl Protection) B
• 19551005270465: Nitrile Examination Gloves, Powder Free (Chemotherapy Drugs Tested and Fentanyl Protection) Blue
• 19551005270458: Nitrile Examination Gloves, Powder Free (Chemotherapy Drugs Tested and Fentanyl Protection) Blue
• 19551005270441: Nitrile Examination Gloves, Powder Free (Chemotherapy Drugs Tested and Fentanyl Protection) Blue
• 19551005270434: Nitrile Examination Gloves, Powder Free (Chemotherapy Drugs Tested and Fentanyl Protection) Blue
• 19551005270427: Nitrile Examination Gloves, Powder Free (Chemotherapy Drugs Tested and Fentanyl Protection) Blue
• 19551005270410: Nitrile Examination Gloves, Powder Free (Chemotherapy Drugs Tested and Fentanyl Protection) Blue
• 19551005270403: Nitrile Examination Gloves, Powder Free (Chemotherapy Drugs Tested and Fentanyl Protection) Blue
• 19551005270250: Latex Examination Gloves, Powder Free Blue - XXL
• 19551005270243: Latex Examination Gloves, Powder Free Blue - XL
• 19551005270236: Latex Examination Gloves, Powder Free Blue - L
• 19551005270229: Latex Examination Gloves, Powder Free Blue - M
• 19551005270212: Latex Examination Gloves, Powder Free Blue - S
• 19551005270205: Latex Examination Gloves, Powder Free Blue - XS
• 19551005270199: Latex Examination Gloves, Powder Free Blue - XXS
• 19551005270182: Nitrile Examination Gloves Powder Free Chemo Tested Blue- XXL
• 19551005270175: Nitrile Examination Gloves Powder Free Chemo Tested Blue- XL
• 19551005270168: Nitrile Examination Gloves Powder Free Chemo Tested Blue- L
• 19551005270151: Nitrile Examination Gloves Powder Free Chemo Tested Blue- M
• 29551005270141: Nitrile Examination Gloves Powder Free Chemo Tested Blue- S
• 19551005270137: Nitrile Examination Gloves Powder Free Chemo Tested Blue- XS
• 19551005270120: Nitrile Examination Gloves Powder Free Chemo Tested Blue- XXS