SurgiMac

GUDID D1054116S1001

Surgimac LLC

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

• Primary Device ID: D1054116S1001
• NIH Device Record Key: 2ed60441-aebb-41eb-999c-4b2baaf1ca3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SurgiMac
• Version Model Number: 4116S
• Company DUNS: 060635048
• Company Name: Surgimac LLC
• 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: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D1054116S100 [Unit of Use]
HIBCC	D1054116S1001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170136

FDA Product Code

• OPJ: Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

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: 2022-11-16
• Device Publish Date: 2022-11-08

On-Brand Devices [SurgiMac ]

• D1055116XL200: 5116XLCASE
• D1055116S200: 5116SCASE
• D1055116M200: 5116MCASE
• D1055116L200: 5116LCASE
• D1054116XL100: 4116XLCASE
• D1054116S100: 4116SCASE
• D1054116S1001: 4116S
• D1054116M100: 4116MCASE
• D1054116L100: 4116LCASE
• D056116SBLKCASE100: 6116SCASE
• D056116SBLK100: 6116S
• D056116MBLKCASE100: 6116SMCASE
• D056116MBLK100: 6116M
• DSVEGLMVNLC100: SVEGLSCase
• DSVEGLMVNL100: SVEGLS
• D1052215XS1000: 2215XS-Case
• D1052115XS1000: 2115XS-Case
• D1052215XS1: 2215XS
• D1052115XS1: 2115XS
• D1052219XL1000: 2219XL-Case
• D1052119XL1000: 2119XL-Case
• D1052219XL1: 2219XL
• D1052119XL1: 2119XL
• D1052216S1000: 2216S-Case
• D1052116S1000: 2116S-Case
• D1052216S1: 2216S
• D1052116S1: 2116S
• D1052217M1000: 2217M-Case
• D1052117M1000: 2117M-Case
• D1052217M1: 2217M
• D1052117M1: 2117M
• D1052218L1000: 2218L-Case
• D1052118L1000: 2118L-Case
• D1052218L1: 2218L
• D1052118L1: 2118L
• D1057115XS100: 7115-XS
• D1057119XL100: 7119-XL
• D1057118L1000: 7119-XL-Case
• D1057117M1000: 7117-M-Case
• D1057116S1000: 7116-S-Case
• D1057115XS1000: 7115-XS-Case
• D1057116S100: 7116-S
• D1057117M100: 7117-M
• D1057118L100: 7118-L
• D1054119L1000: Black Nitrile 100 ct. Extra Large. Case
• D1054118L1000: Black Nitrile 100 ct. Large. Case
• D1054118L1: Black Nitrile 100 ct. Large
• D1052315XS3000: Blue Nitrile 300 ct. Extra Small. Case. MaxFit.
• D1052315XS3: Blue Nitrile 300 ct. Extra Small. MaxFit.
• D1052215XS2000: Blue Nitrile 200 ct. Extra Small. Case. MaxFit.