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FDA 510(k)

RESIST(TM) ORTHOPAEDIC SURGICAL GLOVE

K-Number: K913893 · 1992-10-23

ApplicantDepuy, Inc.
Decision Date1992-10-23
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RESIST(TM) ORTHOPAEDIC SURGICAL GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1992-10-23 under 510(k) number K913893. 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 RESIST(TM) ORTHOPAEDIC SURGICAL GLOVE?

RESIST(TM) ORTHOPAEDIC SURGICAL GLOVE is a medical device that received FDA 510(k) clearance on 1992-10-23. The listed applicant is Depuy, Inc.. The 510(k) number is K913893.

When did RESIST(TM) ORTHOPAEDIC SURGICAL GLOVE receive FDA 510(k) clearance?

RESIST(TM) ORTHOPAEDIC SURGICAL GLOVE received FDA 510(k) clearance on 1992-10-23, under 510(k) number K913893.

Who is the listed applicant for RESIST(TM) ORTHOPAEDIC SURGICAL GLOVE?

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

What is the FDA product code for RESIST(TM) ORTHOPAEDIC SURGICAL GLOVE?

The FDA product code for RESIST(TM) ORTHOPAEDIC SURGICAL GLOVE is KGO.

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Other records listing Depuy, Inc. as applicant

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K043058PINNACLE CONSTRAINED ACETABULAR LINERSK042664LPS UPPER EXTREMITYK041085LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARYK033959LPSK040544DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062K021478DELTA SHOULDER

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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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