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FDA 510(k)

ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES

K-Number: K011721 · 2001-08-14

ApplicantAllegiance Healthcare Corp.
Decision Date2001-08-14
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Allegiance Healthcare Corp.. It received FDA 510(k) clearance on 2001-08-14 under 510(k) number K011721. 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 ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES?

ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES is a medical device that received FDA 510(k) clearance on 2001-08-14. The listed applicant is Allegiance Healthcare Corp.. The 510(k) number is K011721.

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

ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES received FDA 510(k) clearance on 2001-08-14, under 510(k) number K011721.

Who is the listed applicant for ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES?

The FDA 510(k) record lists Allegiance Healthcare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES?

The FDA product code for ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES is KGO.

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Other records listing Allegiance Healthcare Corp. 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.

K023673AIRLIFE DEMAND NASAL CANNULAK023419TRILAMINATE DRAPES/TIBURONK024120MODIFICATION TO TEMNO BIOPSY NEEDLESK024292MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIMK024102DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMK023425DRAPES WITH ABSORBENT REINFORCEMENT

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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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