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FDA 510(k)

PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE

K-Number: K972009 · 1997-09-12

ApplicantTillotson Healthcare Corp.
Decision Date1997-09-12
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Tillotson Healthcare Corp.. It received FDA 510(k) clearance on 1997-09-12 under 510(k) number K972009. 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 PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE?

PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE is a medical device that received FDA 510(k) clearance on 1997-09-12. The listed applicant is Tillotson Healthcare Corp.. The 510(k) number is K972009.

When did PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE receive FDA 510(k) clearance?

PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE received FDA 510(k) clearance on 1997-09-12, under 510(k) number K972009.

Who is the listed applicant for PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE?

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

What is the FDA product code for PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE?

The FDA product code for PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE is KGO.

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Other records listing Tillotson Healthcare Corp. as applicant

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.

K021007ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE MADE FROM ALLOTEX AN ENZYME TREATED NATURALK013324HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREATK013016TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVEK013286CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE VERAK011497CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVEK002718ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB

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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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