Tillotson Healthcare Corp.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Tillotson Healthcare Corp.” (first 1995, latest 2002), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 70 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 13 | 13 |
| LZA | Polymer Patient Examination Glove | 4 | 4 |
| KGO | Surgeon'S Gloves | 3 | 3 |
Review panels
- General Hospital (20)
Most recent Tillotson Healthcare Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021007 | ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE MADE FROM ALLOTEX AN ENZYME TREATED NATURAL | LYY | 2002-07-05 | 99 |
| K013324 | HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT | KGO | 2001-11-29 | 55 |
| K013016 | TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE | LZA | 2001-10-19 | 42 |
| K013286 | CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE VERA | LYY | 2001-10-12 | 10 |
| K011497 | CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVE | LZA | 2001-07-10 | 56 |
| K002718 | ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB | LYY | 2001-05-01 | 243 |
| K004048 | SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | 2001-02-06 | 39 |
| K002719 | FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM 200 MICROGRAMS OR LESS AND MADE FROM A | LYY | 2001-01-26 | 148 |
| K002720 | FORMULA ONE STERILE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) MADE FROM ALLO | LYY | 2000-11-09 | 70 |
| K000745 | SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM | LYY | 2000-05-03 | 56 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tillotson Healthcare Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Tillotson Rubber Co., Inc. (6 510(k)s)
- Tillotson Corp. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tillotson Healthcare Corp.?
FDA lists 20 510(k) clearances under the applicant name “Tillotson Healthcare Corp.” (first 1995, latest 2002), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tillotson Healthcare Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tillotson Healthcare Corp. is 70 days.
Which FDA product codes appear under Tillotson Healthcare Corp.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 13); LZA (Polymer Patient Examination Glove, 4); KGO (Surgeon'S Gloves, 3).
Next steps
- See all 20 Tillotson Healthcare Corp. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Tillotson Healthcare Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.