Global Protection Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Global Protection Corp.” (first 1997, latest 2025), plus 1 De Novo decision, across 6 product codes in 3 review panels. Median 510(k) review time under this name: 234 days. Since 2017 the median was 234 days, against 119 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 241 |
| 2021 | 1 | 274 |
| 2022 | 1 | 256 |
| 2023 | 1 | 339 |
| 2024 | 1 | 144 |
| 2025 | 3 | 203 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Global Protection Corp. took a median 234 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIS | Condom | 4 | 4 |
| MOL | Condom, Synthetic | 2 | 2 |
| NUC | Lubricant, Personal | 2 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
| QRZ | External Condom For Anal Intercourse Or Vaginal Intercourse | 1 | 0 |
Review panels
Most recent Global Protection Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250142 | Water-based Lubricant | NUC | 2025-08-08 | 203 |
| K243972 | Plain Water-based Lubricant | NUC | 2025-08-08 | 228 |
| K243967 | ONE Nitrile Condom | MOL | 2025-04-08 | 106 |
| K240896 | ONE Nitrile Condom | MOL | 2024-08-23 | 144 |
| K223214 | Powder-Free Nitrile Examination Gloves | LZA | 2023-09-21 | 339 |
| K213087 | Natural Rubber Latex Ultrasound Transducer Probe Covers | ITX | 2022-06-07 | 256 |
| K203536 | Male Latex Condom | HIS | 2021-09-03 | 274 |
| K193578 | Non-spermicidal Lubricated Male Latex Condom | HIS | 2020-08-20 | 241 |
| K024324 | LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9 | HIS | 2003-03-25 | 89 |
| K960552 | KNIGHT LIGHT NONLUBRICATED CONDOM | HIS | 1997-11-20 | 651 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN210034 | De Novo | External Condom For Anal Intercourse Or Vaginal Intercourse | 2022-02-23 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2007-09-11.
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 Global Protection Corp. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02753842: Condom Performance in a Longitudinal Enhanced Assessment of User Experiences (Completed, started 2016-05)
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.
- Global Medical Prods, Inc. (9 510(k)s)
- Global Endoscopy, Inc. (7 510(k)s)
- Global Medical Products, Ltd. (6 510(k)s)
- Global Instrumentation, LLC (5 510(k)s)
- Global Treasure Industries , Ltd. (5 510(k)s)
- Global Fabtech Wheelchair (Shanghai) Co., Ltd. (4 510(k)s)
- Global USA Distribution, LLC (4 510(k)s)
- Global Healthcare, Inc. (3 510(k)s)
- Global Manufacturing Technology (3 510(k)s)
- Global Orthopaedic Technology, USA, Inc. (3 510(k)s)
- Global TV Concepts, Ltd. (3 510(k)s)
- Global Blood Resources, LLC (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Global Protection Corp.?
FDA lists 10 510(k) clearances under the applicant name “Global Protection Corp.” (first 1997, latest 2025), plus 1 De Novo decision, across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Global Protection Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Global Protection Corp. is 234 days. Since 2017: 234 days, versus 119 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Global Protection Corp.?
The most frequent FDA product codes under this applicant name are HIS (Condom, 4); MOL (Condom, Synthetic, 2); NUC (Lubricant, Personal, 2).
Next steps
- See all 10 Global Protection Corp. clearances with predicates and recalls
- Run predicate analysis for product code HIS, Global Protection 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.