P.T. Healthcare Glovindo: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “P.T. Healthcare Glovindo” (first 1993, latest 2002), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 172 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 | 5 | 5 |
| LZA | Polymer Patient Examination Glove | 2 | 2 |
Review panels
- General Hospital (7)
Most recent P.T. Healthcare Glovindo 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021659 | PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS) | LYY | 2002-08-12 | 84 |
| K010232 | PRE-POWDERED NITRILE EXAMINATION GLOVES | LZA | 2001-09-21 | 240 |
| K010233 | POWDER FREE NITRILE EXAMINATION GLOVES | LZA | 2001-06-22 | 149 |
| K000838 | DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | 2000-10-23 | 223 |
| K974853 | LATEX (POWDER FREE) LOW PROTEIN | LYY | 1998-02-09 | 42 |
| K931406 | POWDER-FREE PATIENT EXAMINATION GLOVES | LYY | 1993-10-21 | 216 |
| K930995 | POWDERED EXAMINATION GLOVES | LYY | 1993-08-16 | 172 |
Recalls
openFDA lists no recalls under a recalling firm named P.T. Healthcare Glovindo.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under P.T. Healthcare Glovindo?
FDA lists 7 510(k) clearances under the applicant name “P.T. Healthcare Glovindo” (first 1993, latest 2002), across 2 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 P.T. Healthcare Glovindo?
The median time from FDA receipt to decision across 510(k)s cleared under the name P.T. Healthcare Glovindo is 172 days.
Which FDA product codes appear under P.T. Healthcare Glovindo?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 5); LZA (Polymer Patient Examination Glove, 2).
Next steps
- See all 7 P.T. Healthcare Glovindo clearances with predicates and recalls
- Run predicate analysis for product code LYY, P.T. Healthcare Glovindo'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.