Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AMPRI

K-Number: K954002 · 1996-01-29

ApplicantAmpri Rubberware Industries Sdn Bhd
Decision Date1996-01-29
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AMPRI is the device name listed in this FDA 510(k) record. The listed applicant is Ampri Rubberware Industries Sdn Bhd. It received FDA 510(k) clearance on 1996-01-29 under 510(k) number K954002. 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 AMPRI?

AMPRI is a medical device that received FDA 510(k) clearance on 1996-01-29. The listed applicant is Ampri Rubberware Industries Sdn Bhd. The 510(k) number is K954002.

When did AMPRI receive FDA 510(k) clearance?

AMPRI received FDA 510(k) clearance on 1996-01-29, under 510(k) number K954002.

Who is the listed applicant for AMPRI?

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

What is the FDA product code for AMPRI?

The FDA product code for AMPRI 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ampri Rubberware 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.

K990677ABSOGEL CHEMOTHERAPHY GLOVESK990812POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTAK952833AMPRIK945948ABSOGEL STERILE POWDER-FREE SURGICAL GLOVESK946056ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE)K892176CORRECT TOUCH SURGEONS GLOVES

View all 8 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.

↑