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FDA 510(k)

ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM

K-Number: K964980 · 1997-03-06

ApplicantMaxxim Medical
Decision Date1997-03-06
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM is the device name listed in this FDA 510(k) record. The listed applicant is Maxxim Medical. It received FDA 510(k) clearance on 1997-03-06 under 510(k) number K964980. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM?

ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM is a medical device that received FDA 510(k) clearance on 1997-03-06. The listed applicant is Maxxim Medical. The 510(k) number is K964980.

When did ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM receive FDA 510(k) clearance?

ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM received FDA 510(k) clearance on 1997-03-06, under 510(k) number K964980.

Who is the listed applicant for ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM?

The FDA 510(k) record lists Maxxim Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM?

The FDA product code for ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM is KGO.

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Other records listing Maxxim Medical as applicant

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K023236SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVESK021452STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVEK011905SNIPER ELITE MODEL-OR-E3872XX SERIESK002847INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XXK010297SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE)K002933STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES

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Related Devices (Code: KGO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateHartalega NGC Sdn. Bhd.K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company LimitedK250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbHK240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd.K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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