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FDA 510(k)

PERRY XTENDA CUFF SURGICAL GLOVES

K-Number: K905537 · 1991-01-11

ApplicantSmith & Nephew Perry
Decision Date1991-01-11
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PERRY XTENDA CUFF SURGICAL GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Perry. It received FDA 510(k) clearance on 1991-01-11 under 510(k) number K905537. 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 PERRY XTENDA CUFF SURGICAL GLOVES?

PERRY XTENDA CUFF SURGICAL GLOVES is a medical device that received FDA 510(k) clearance on 1991-01-11. The listed applicant is Smith & Nephew Perry. The 510(k) number is K905537.

When did PERRY XTENDA CUFF SURGICAL GLOVES receive FDA 510(k) clearance?

PERRY XTENDA CUFF SURGICAL GLOVES received FDA 510(k) clearance on 1991-01-11, under 510(k) number K905537.

Who is the listed applicant for PERRY XTENDA CUFF SURGICAL GLOVES?

The FDA 510(k) record lists Smith & Nephew Perry as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERRY XTENDA CUFF SURGICAL GLOVES?

The FDA product code for PERRY XTENDA CUFF SURGICAL GLOVES is KGO.

Related Clinical Trials

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.

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Other records listing Smith & Nephew Perry 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.

K932664ENCORE POWDER-FREE SURGICAL GLOVES ORTHOPAEDIAK932665ENCORE POWDER-FREE SURGICAL GLOVES MICROPTICK931399PERRY ENHANCED PROTECTION LATEX SURGICAL GLOVEK923929PERRY POWDER-FREE GLOVES, STYLE 45GK922379STERILE LATEX EXAMINATION GLOVESK914445PERRY(R) NATURAL POWDER-FREE GLOVES, STYLE 45

View all 10 devices →

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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