Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Global Protection Corp. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
228 daysmedian FDA review time
339 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250142 | Water-based Lubricant | Global Protection Corp. | 2025-08-08 | 203 | 0 |
| K243972 | Plain Water-based Lubricant | Global Protection Corp. | 2025-08-08 | 228 | 0 |
| K243967 | ONE Nitrile Condom | Global Protection Corp. | 2025-04-08 | 106 | 0 |
| K240896 | ONE Nitrile Condom | Global Protection Corp. | 2024-08-23 | 144 | 0 |
| K223214 | Powder-Free Nitrile Examination Gloves | Global Protection Corp. | 2023-09-21 | 339 | 0 |
| K213087 | Natural Rubber Latex Ultrasound Transducer Probe Covers | Global Protection Corp. | 2022-06-07 | 256 | 0 |
| DEN210034 | ONE Male Condom | Global Protection Corp. | 2022-02-23 | 181 | 0 |
| K203536 | Male Latex Condom | Global Protection Corp. | 2021-09-03 | 274 | 0 |
| K193578 | Non-spermicidal Lubricated Male Latex Condom | Global Protection Corp. | 2020-08-20 | 241 | 0 |
| K024324 | LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9 | Global Protection Corp. | 2003-03-25 | 89 | 0 |
| K960552 | KNIGHT LIGHT NONLUBRICATED CONDOM | Global Protection Corp. | 1997-11-20 | 651 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda