SafeHealth

GUDID 04719886610123

Nitrile Gloves, PF, Blueple F XL

PM GLOVES U S A INC

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

• Primary Device ID: 04719886610123
• NIH Device Record Key: c4a6b63e-ac96-4faa-9d7d-1c99316895df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeHealth
• Version Model Number: GNFB14245
• Company DUNS: 361339419
• Company Name: PM GLOVES U S A INC
• 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: true

Customer Support Contacts

• Phone: +1(909) 4659188
• Email: xxx@xx.xx
• Phone: +1(909) 4659188
• Email: xxx@xx.xx
• Phone: +1(909) 4659188
• Email: xxx@xx.xx
• Phone: +1(909) 4659188
• Email: xxx@xx.xx
• Phone: +1(909) 4659188
• Email: xxx@xx.xx
• Phone: +1(909) 4659188
• Email: xxx@xx.xx
• Phone: +1(909) 4659188
• Email: xxx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719886610086 [Primary]
GS1	04719886610123 [Package]; Contains: 04719886610086; Package: case [1000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171422

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: 2022-11-10
• Device Publish Date: 2022-11-02

On-Brand Devices [SafeHealth]

• 04712832881684: NITRILE EXAMINATION GLOVES, Blue (XL)
• 04712832881677: NITRILE EXAMINATION GLOVES, Blue (L)
• 04712832881660: NITRILE EXAMINATION GLOVES, Blue (M)
• 04712832881653: NITRILE EXAMINATION GLOVES, Blue (S)
• 04712832881646: NITRILE EXAMINATION GLOVES, Blue (XS)
• 04712832881585: VINYL EXAMINATION GLOVES, Clear (XL)
• 04712832881578: VINYL EXAMINATION GLOVES, Clear (L)
• 04712832881561: VINYL EXAMINATION GLOVES, Clear (M)
• 04712832881554: VINYL EXAMINATION GLOVES, Clear (S)
• 04712832881547: VINYL EXAMINATION GLOVES, Clear (XS)
• 04712832881073: NITRILE EXAMINATION GLOVES, Blue (XL)
• 04712832881066: NITRILE EXAMINATION GLOVES, Blue (L)
• 04712832881059: NITRILE EXAMINATION GLOVES, Blue (M)
• 04712832881042: NITRILE EXAMINATION GLOVES, Blue (S)
• 04712832881035: NITRILE EXAMINATION GLOVES, Blue (XS)
• 04712832881028: VINYL EXAMINATION GLOVES, Clear (XL)
• 04712832880632: VINYL EXAMINATION GLOVES, Clear (L)
• 04712832881004: VINYL EXAMINATION GLOVES, Clear (M)
• 04712832880991: VINYL EXAMINATION GLOVES, Clear (S)
• 04712832880984: VINYL EXAMINATION GLOVES, Clear (XS)
• 04719886610123: Nitrile Gloves, PF, Blueple F XL
• 04719886610116: Nitrile Gloves, PF, Blueple F L
• 04719886610062: Nitrile Gloves, PF, Blueple F M
• 04719886610055: Nitrile Gloves, PF, Blueple F S
• 04712832889949: Nitrile Gloves, PF, Cobalt Blue F XL
• 04712832889932: Nitrile Gloves, PF, Cobalt Blue F L
• 04712832889925: Nitrile Gloves, PF, Cobalt Blue F M
• 04712832889918: Nitrile Gloves, PF, Cobalt Blue F S
• 04712832886801: Vinyl Gloves, PF, ECO Exam Aloe XL
• 04712832886795: Vinyl Gloves, PF, ECO Exam Aloe L
• 04712832886788: Vinyl Gloves, PF, ECO Exam Aloe M
• 04712832886771: Vinyl Gloves, PF, ECO Exam Aloe S
• 04712832884340: Nitrile Gloves, PF, RoyalBlue F CHEMO I XL
• 04712832884333: Nitrile Gloves, PF, RoyalBlue F CHEMO I L
• 04712832884326: Nitrile Gloves,PF, RoyalBlue F CHEMO I M
• 04712832884319: Nitrile Gloves, PF, RoyalBlue F CHEMO I S
• 04712832884302: Nitrile Gloves, PF, RoyalBlue F CHEMO I XS
• 04712832882612: Vinyl Gloves, PF, ECO Blue NITRO-V XL
• 04712832882605: Vinyl Gloves, PF, ECO Blue NITRO-V L
• 04712832882599: Vinyl Gloves, PF, ECO Blue NITRO-V M
• 04712832882582: Vinyl Gloves, PF, ECO Blue NITRO-V S
• 04712832881981: Nitrile Gloves, PF, Blue2 F CHEMO I XL
• 04712832881974: Nitrile Gloves, PF, Blue2 F CHEMO I L
• 00889526407803: Vinyl Gloves, PF, Exam ECO Clear XL
• 00889526397203: Vinyl Gloves, PF, Exam ECO Clear S
• 04712832882513: Vinyl Gloves, PF,Exam ECO Stretch XL
• 04712832882506: Vinyl Gloves, PF,Exam ECO Stretch L
• 04712832882490: Vinyl Gloves, PF,Exam ECO Stretch M
• 04712832882483: Vinyl Gloves, PF,Exam ECO Stretch S