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FDA 510(k)

POWDERFREE POLYISOPRENE SURGICAL GLOVES

K-Number: K112654 · 2012-02-17

ApplicantPt. Medisafe Technologies
Decision Date2012-02-17
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POWDERFREE POLYISOPRENE SURGICAL GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Medisafe Technologies. It received FDA 510(k) clearance on 2012-02-17 under 510(k) number K112654. 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 POWDERFREE POLYISOPRENE SURGICAL GLOVES?

POWDERFREE POLYISOPRENE SURGICAL GLOVES is a medical device that received FDA 510(k) clearance on 2012-02-17. The listed applicant is Pt. Medisafe Technologies. The 510(k) number is K112654.

When did POWDERFREE POLYISOPRENE SURGICAL GLOVES receive FDA 510(k) clearance?

POWDERFREE POLYISOPRENE SURGICAL GLOVES received FDA 510(k) clearance on 2012-02-17, under 510(k) number K112654.

Who is the listed applicant for POWDERFREE POLYISOPRENE SURGICAL GLOVES?

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

What is the FDA product code for POWDERFREE POLYISOPRENE SURGICAL GLOVES?

The FDA product code for POWDERFREE POLYISOPRENE SURGICAL GLOVES is KGO.

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Other records listing Pt. Medisafe Technologies 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.

K201774Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy DrugsK182176Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy DrugsK173258Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with ChemotherapyK163041Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin EK102623BLUE POWDERFREE NITRILE EXAMINATION GLOVEK102620POWDERFREE BLACK NITRILE EXAMINATION 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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