Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
380 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K952588 | ROYAL SHIELD NON-STERILE LATEX EXAMINATION GLOVES | Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. | 1995-10-12 | 129 | 0 |
| K952590 | ROYAL SHIELD NON-STERILE PINK COLOERED, STRAWBERRY SCENTED L | Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. | 1995-08-14 | 70 | 0 |
| K952591 | ROYAL SHIELD NON-STERILE BLUE COLORED BUBBLE GUM SCENTED LAT | Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. | 1995-08-11 | 67 | 0 |
| K926132 | ROYAL SHIELD SHIELD GLOVES | Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. | 1993-12-22 | 380 | 0 |
| K890907 | ROYAL SHIELD LATEX EXAMINATION GLOVES(TM) | Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. | 1989-04-26 | 61 | 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