Pt. Medisafe Technologies: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Pt. Medisafe Technologies” (first 2001, latest 2020), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 119 days. Since 2017 the median was 153 days, against 118 days for all cleared 510(k)s in the same product codes. 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 | 1 | 158 |
| 2013 | 0 | — |
| 2014 | 1 | 213 |
| 2015 | 2 | 364 |
| 2016 | 0 | — |
| 2017 | 1 | 114 |
| 2018 | 1 | 192 |
| 2019 | 1 | 230 |
| 2020 | 1 | 79 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Pt. Medisafe Technologies took a median 153 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 10 | 10 |
| KGO | Surgeon'S Gloves | 8 | 8 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (19)
Most recent Pt. Medisafe Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201774 | Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs | KGO | 2020-09-16 | 79 |
| K182176 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs | KGO | 2019-03-28 | 230 |
| K173258 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy | KGO | 2018-04-20 | 192 |
| K163041 | Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E | LZA | 2017-02-22 | 114 |
| K142941 | Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color. | KGO | 2015-11-02 | 389 |
| K142190 | Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (Green) Tested for Use with Chemotherapy Drugs | KGO | 2015-07-14 | 340 |
| K133689 | POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK | LZA | 2014-07-03 | 213 |
| K112654 | POWDERFREE POLYISOPRENE SURGICAL GLOVES | KGO | 2012-02-17 | 158 |
| K102623 | BLUE POWDERFREE NITRILE EXAMINATION GLOVE | LZA | 2011-06-06 | 266 |
| K102620 | POWDERFREE BLACK NITRILE EXAMINATION GLOVES | LZA | 2010-11-22 | 70 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pt. Medisafe Technologies.
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.
Device clinical trials
An industry sponsor named Pt. Medisafe Technologies is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04402476: Skin Sensitisation (Modified Draize-95 Test) (Completed, started 2019-11-23)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pt. Medisafe Technologies?
FDA lists 19 510(k) clearances under the applicant name “Pt. Medisafe Technologies” (first 2001, latest 2020), 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 Pt. Medisafe Technologies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pt. Medisafe Technologies is 119 days. Since 2017: 153 days, versus 118 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Pt. Medisafe Technologies?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 10); KGO (Surgeon'S Gloves, 8); LYY (Latex Patient Examination Glove, 1).
Next steps
- See all 19 Pt. Medisafe Technologies clearances with predicates and recalls
- Run predicate analysis for product code LZA, Pt. Medisafe Technologies'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.