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FDA 510(k)

HPI SENSI-SHIELD GLOVE KIT

K-Number: K910383 · 1991-03-20

ApplicantHpi, Inc.
Decision Date1991-03-20
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HPI SENSI-SHIELD GLOVE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Hpi, Inc.. It received FDA 510(k) clearance on 1991-03-20 under 510(k) number K910383. 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 HPI SENSI-SHIELD GLOVE KIT?

HPI SENSI-SHIELD GLOVE KIT is a medical device that received FDA 510(k) clearance on 1991-03-20. The listed applicant is Hpi, Inc.. The 510(k) number is K910383.

When did HPI SENSI-SHIELD GLOVE KIT receive FDA 510(k) clearance?

HPI SENSI-SHIELD GLOVE KIT received FDA 510(k) clearance on 1991-03-20, under 510(k) number K910383.

Who is the listed applicant for HPI SENSI-SHIELD GLOVE KIT?

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

What is the FDA product code for HPI SENSI-SHIELD GLOVE KIT?

The FDA product code for HPI SENSI-SHIELD GLOVE KIT is KGO.

Related Clinical Trials

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Other records listing Hpi, 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.

K922116POWDER FREE NITRILE GLOVEK915086HPI BROWN NITRILE SENSI-GRIP SURGICAL GLOVESK904878SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.K905086HPI TRI-RADS VINYL RADIATION PROTECTION GLOVESK901608HPI POWDER FREE NON-STERILE EXAMINATION GLOVES

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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