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FDA 510(k)

MICRO-THIN SURGICAL GLOVE

K-Number: K831565 · 1983-07-19

ApplicantAnsell, Inc.
Decision Date1983-07-19
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICRO-THIN SURGICAL GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Ansell, Inc.. It received FDA 510(k) clearance on 1983-07-19 under 510(k) number K831565. 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 MICRO-THIN SURGICAL GLOVE?

MICRO-THIN SURGICAL GLOVE is a medical device that received FDA 510(k) clearance on 1983-07-19. The listed applicant is Ansell, Inc.. The 510(k) number is K831565.

When did MICRO-THIN SURGICAL GLOVE receive FDA 510(k) clearance?

MICRO-THIN SURGICAL GLOVE received FDA 510(k) clearance on 1983-07-19, under 510(k) number K831565.

Who is the listed applicant for MICRO-THIN SURGICAL GLOVE?

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

What is the FDA product code for MICRO-THIN SURGICAL GLOVE?

The FDA product code for MICRO-THIN SURGICAL GLOVE is KGO.

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Other records listing Ansell, Inc. 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.

K984392ANSELL CONDOMSK983518LIFESTYLES XTRA PLEASUREK940047SPERMICIDALLY LUBRICATED CONDOMK953379HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVEK945766HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVESK945767POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT 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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