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FDA 510(k)

ACRYLIC DIPPED LATEX SURGICAL GLOVES - STERILE

K-Number: K945505 · 1995-08-18

ApplicantGanz Industries Sdn. Bhd.
Decision Date1995-08-18
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACRYLIC DIPPED LATEX SURGICAL GLOVES - STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Ganz Industries Sdn. Bhd.. It received FDA 510(k) clearance on 1995-08-18 under 510(k) number K945505. 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 ACRYLIC DIPPED LATEX SURGICAL GLOVES - STERILE?

ACRYLIC DIPPED LATEX SURGICAL GLOVES - STERILE is a medical device that received FDA 510(k) clearance on 1995-08-18. The listed applicant is Ganz Industries Sdn. Bhd.. The 510(k) number is K945505.

When did ACRYLIC DIPPED LATEX SURGICAL GLOVES - STERILE receive FDA 510(k) clearance?

ACRYLIC DIPPED LATEX SURGICAL GLOVES - STERILE received FDA 510(k) clearance on 1995-08-18, under 510(k) number K945505.

Who is the listed applicant for ACRYLIC DIPPED LATEX SURGICAL GLOVES - STERILE?

The FDA 510(k) record lists Ganz Industries Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACRYLIC DIPPED LATEX SURGICAL GLOVES - STERILE?

The FDA product code for ACRYLIC DIPPED LATEX SURGICAL GLOVES - STERILE 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 Ganz Industries Sdn. Bhd. 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.

K954487PRE POWDERED LATEX EXAMINATION GLOVESK945506ACRYLIC DIPPED LATEX EXAMINATION GLOVESK945504ACRYLIC DIPPED LATEX EXAMINATION GLOVES - STERILE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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