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FDA 510(k)

BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES

K-Number: K882392 · 1988-08-26

ApplicantRoseburg SA
Decision Date1988-08-26
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Roseburg SA. It received FDA 510(k) clearance on 1988-08-26 under 510(k) number K882392. 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 BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES?

BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES is a medical device that received FDA 510(k) clearance on 1988-08-26. The listed applicant is Roseburg SA. The 510(k) number is K882392.

When did BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES receive FDA 510(k) clearance?

BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES received FDA 510(k) clearance on 1988-08-26, under 510(k) number K882392.

Who is the listed applicant for BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES?

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

What is the FDA product code for BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES?

The FDA product code for BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES is KGO.

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Other records listing Roseburg SA 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.

K931155STAPLE, FIXATION BONE; SCREW FIXATION BONEK890081CALIUS-ISABEL CANOVAS SUNGLASSESK885275ASSENAT-BLESCHET SUNGLASSESK872715UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERYK874317POIRIER KID-ROLLER MANUAL WHEELCHAIRK872714S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY

View all 24 devices →

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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