Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ansell, Inc. — Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
390 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K984392 | ANSELL CONDOMS | Ansell, Inc. | 1999-07-21 | 225 | 0 |
| K983518 | LIFESTYLES XTRA PLEASURE | Ansell, Inc. | 1999-07-06 | 272 | 0 |
| K940047 | SPERMICIDALLY LUBRICATED CONDOM | Ansell, Inc. | 1995-12-19 | 713 | 0 |
| K953379 | HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX | Ansell, Inc. | 1995-09-27 | 70 | 0 |
| K945766 | HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLO | Ansell, Inc. | 1995-08-07 | 259 | 0 |
| K945767 | POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION | Ansell, Inc. | 1995-03-02 | 101 | 0 |
| K940045 | CONDOM | Ansell, Inc. | 1995-01-30 | 390 | 0 |
| K940046 | NON-LUBRICATED CONDOM | Ansell, Inc. | 1995-01-30 | 390 | 0 |
| K913766 | ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES | Ansell, Inc. | 1993-03-11 | 567 | 0 |
| K914760 | LATEX EXAMINATION GLOVES | Ansell, Inc. | 1992-01-17 | 87 | 0 |
| K903108 | PATIENT EXAM GLOVES (FINISH W/USP STARCH POWDER) | Ansell, Inc. | 1990-08-29 | 50 | 0 |
| K903107 | PATIENT EXAM GLOVES (DUSTED W/USP STARCH POWDER) | Ansell, Inc. | 1990-08-29 | 51 | 0 |
| K901112 | G.S.A. COLORED CONDOMS | Ansell, Inc. | 1990-03-27 | 18 | 0 |
| K901111 | NUDA (CURRENTLY CALLED ULTRA SENSITIVE) | Ansell, Inc. | 1990-03-27 | 18 | 0 |
| K897081 | ANSELL CONFORM GREEN EXAMINATION GLOVES | Ansell, Inc. | 1990-03-26 | 97 | 0 |
| K895660 | ANSELL DENTA GLOVES | Ansell, Inc. | 1990-01-02 | 104 | 0 |
| K892289 | PATIENT EXAMINATION GLOVES (LATEX) | Ansell, Inc. | 1989-06-23 | 78 | 0 |
| K892288 | PATIENT EXAMINATION GLOVES (LATEX) | Ansell, Inc. | 1989-06-09 | 64 | 0 |
| K892106 | STERILE EXAM GLOVES | Ansell, Inc. | 1989-05-31 | 58 | 0 |
| K892325 | NON-STERILE EXAM GLOVES | Ansell, Inc. | 1989-05-31 | 58 | 0 |
| K882389 | KISS OF MINT(TM) NON-LUBRICATED CONDOM | Ansell, Inc. | 1988-10-20 | 132 | 0 |
| K871304 | LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9 | Ansell, Inc. | 1987-06-11 | 71 | 0 |
| K864400 | EXTRA STRONG CONDOM | Ansell, Inc. | 1987-02-02 | 88 | 0 |
| K850635 | ANSELL NO POWDER SURGEON'S GLOVES | Ansell, Inc. | 1985-06-26 | 127 | 0 |
| K831565 | MICRO-THIN SURGICAL GLOVE | Ansell, Inc. | 1983-07-19 | 64 | 0 |
| K831564 | ORTHOPEDIC SURGICAL GLOVE | Ansell, Inc. | 1983-07-12 | 57 | 0 |
| K830691 | PRIME | Ansell, Inc. | 1983-03-31 | 30 | 0 |
| K822792 | NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT | Ansell, Inc. | 1982-09-30 | 15 | 0 |
| K820665 | DERMA PRENE | Ansell, Inc. | 1982-05-03 | 53 | 0 |
| K802641 | GAMMEX SURGICAL GLOVES | Ansell, Inc. | 1980-12-11 | 48 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda