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FDA 510(k)

SANOFLEX-STERILE LATEX SURGICAL GLOVES

K-Number: K903513 · 1990-09-14

ApplicantLowenkamp Intl., Inc.
Decision Date1990-09-14
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SANOFLEX-STERILE LATEX SURGICAL GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Lowenkamp Intl., Inc.. It received FDA 510(k) clearance on 1990-09-14 under 510(k) number K903513. 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 SANOFLEX-STERILE LATEX SURGICAL GLOVES?

SANOFLEX-STERILE LATEX SURGICAL GLOVES is a medical device that received FDA 510(k) clearance on 1990-09-14. The listed applicant is Lowenkamp Intl., Inc.. The 510(k) number is K903513.

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

SANOFLEX-STERILE LATEX SURGICAL GLOVES received FDA 510(k) clearance on 1990-09-14, under 510(k) number K903513.

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

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

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

The FDA product code for SANOFLEX-STERILE LATEX SURGICAL GLOVES 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 Lowenkamp Intl., 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.

K951940PATIENT EXAMINATION GLOVEK946154MALA LATEX EXAM GLOVES AND SCAN-SUBK910439FOXELL PLUS MULTIPLE (PERSONAL TOUCH TM)

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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