Industrial Clothings, Ltd.: FDA clearances and approvals
Industrial Clothings, Ltd. has 14 FDA 510(k) clearances (first 2000, latest 2013), across 2 product codes in 1 review panel. Median 510(k) review time: 237 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 64 |
| 2013 | 3 | 235 |
| 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 |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 9 | 9 |
| LYY | Latex Patient Examination Glove | 5 | 5 |
Review panels
- General Hospital (14)
Most recent Industrial Clothings, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130846 | MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN | LZA | 2013-08-08 | 134 |
| K122464 | MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, ORANGE | LZA | 2013-04-12 | 242 |
| K122453 | MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY | LZA | 2013-04-05 | 235 |
| K122465 | MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK | LZA | 2012-10-16 | 64 |
| K033496 | MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POWDER FREE FOR CHEMOTHERAPY USE | LYY | 2004-03-09 | 125 |
| K023159 | MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POEDER FREE | LYY | 2002-11-12 | 50 |
| K022781 | MIDAS TOUCH PURPLE NITRILE EXAMINATION GLOVES-POLYMER COATED, POWDER FREE | LZA | 2002-10-08 | 47 |
| K021465 | MIDAS TOUCH LATEX EXAMINATION GLOVES-POLYMER COATED, POWDER FREE | LYY | 2002-05-22 | 15 |
| K000145 | MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDER FREE | LZA | 2000-09-13 | 239 |
| K000143 | MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED | LZA | 2000-09-13 | 239 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Industrial Clothings, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Industrial Clothings, Ltd. have?
Industrial Clothings, Ltd. has 14 FDA 510(k) clearances (first 2000, latest 2013), across 2 product codes in 1 review panel.
How long does FDA take to clear Industrial Clothings, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Industrial Clothings, Ltd.'s cleared 510(k)s is 237 days.
What devices does Industrial Clothings, Ltd. make?
Its most frequent FDA product codes are LZA (Polymer Patient Examination Glove, 9); LYY (Latex Patient Examination Glove, 5).
Has Industrial Clothings, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Industrial Clothings, Ltd. Related entities may recall under other names.
Next steps
- See all 14 Industrial Clothings, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Industrial Clothings, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.