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3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC vs 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: FDAPulse comparison
3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC's review days of 102 is 1.1x 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 93 (36th percentile). 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC is dated 2026-09-25; 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 2026-10-01.
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
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How does 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC compare to 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?
| Field | 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC | 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 |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K261992 | K262208 |
| Device | 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) | 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, Fentanyl Citrate and Simulated Gastric Acid Blue;Non-sterile, Powder Free Nitrile Examination Gloves - Pink |
| Applicant | Solventum US, LLC | Yty Industry (Manjung) Sdn Bhd |
| Specialty / panel | General Hospital | General Hospital |
| Product code | JOJ | LZA |
| Device class | 2 | 1 |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2026-06-15 | 2026-06-30 |
| Decision date | 2026-09-25 | 2026-10-01 |
| Review time (days) | 102 | 93 |
| Third-party review | No | No |
| Applicant location | San Antonio, TX, US | Sitiawan, MY |
| amount percentile | 36th | 33rd |
| Predicate Speed & CAPA Advisory Opportunity Score | 36/100 | 36/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC · 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
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