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Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fe vs TSK OptiXion (K262516): 510(k) cleared for Tsk Laboratory, Japan: FDAPulse comparison

Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fe's review days of 93 is 1.2x TSK OptiXion (K262516): 510(k) cleared for Tsk Laboratory, Japan's 77 (33rd percentile). Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fe is dated 2026-10-01; TSK OptiXion (K262516): 510(k) cleared for Tsk Laboratory, Japan 2026-10-06.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

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How does Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fe compare to TSK OptiXion (K262516): 510(k) cleared for Tsk Laboratory, Japan?

FieldNon-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, FeTSK OptiXion (K262516): 510(k) cleared for Tsk Laboratory, Japan
Record510(k) clearance510(k) clearance
510(k) numberK262208K262516
DeviceNon-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid – Blue;Non-sterile, Powder Free Nitrile Examination Gloves - PinkTSK OptiXion
ApplicantYty Industry (Manjung) Sdn BhdTsk Laboratory, Japan
Specialty / panelGeneral HospitalGeneral Hospital
Product codeLZAQYM
Device class12
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-06-302026-07-21
Decision date2026-10-012026-10-06
Review time (days)9377
Third-party reviewNoNo
Applicant locationSitiawan, MYTochigi-Ken, JP
amount percentile33rd21st
Predicate Speed & CAPA Advisory Opportunity Score36/10036/100
Peer rank and all 500 records (CSV) 🔒 Click to unlock →
Official source URLs for every peer record 🔒 Click to unlock →

Official records: Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fe · TSK OptiXion (K262516): 510(k) cleared for Tsk Laboratory, Japan

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