Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Grand Work Plastic Products Co., Ltd. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
66 daysmedian FDA review time
134 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232444 | Sterile Powder Free Latex Surgical Gloves, Tested for Use wi | Grand Work Plastic Products Co., Ltd. | 2023-12-20 | 128 | 0 |
| K232039 | Sterile Powder Free Nitrile Examination Gloves (Blue), Teste | Grand Work Plastic Products Co., Ltd. | 2023-08-09 | 30 | 0 |
| K230217 | Sterile Polyisoprene Powder Free Surgical Glove, Tested for | Grand Work Plastic Products Co., Ltd. | 2023-05-13 | 107 | 0 |
| K222892 | Powder Free Polyurethane Examination Gloves, Blue color, Tes | Grand Work Plastic Products Co., Ltd. | 2022-12-15 | 83 | 0 |
| K213574 | Nitrile Vinyl Blend Powder Free Examination Gloves (Black) | Grand Work Plastic Products Co., Ltd. | 2022-07-12 | 244 | 0 |
| K220249 | Sterile Nitrile Powder Free Examination Gloves Tested For Us | Grand Work Plastic Products Co., Ltd. | 2022-05-26 | 115 | 0 |
| K220250 | Sterile Powder Free Nitrile Examination Gloves (Blue), Teste | Grand Work Plastic Products Co., Ltd. | 2022-05-11 | 100 | 0 |
| K220240 | Vinyl Co-Polymer Powder-free Examination Gloves, Black | Grand Work Plastic Products Co., Ltd. | 2022-03-31 | 62 | 0 |
| K142409 | Vinyl Co-Polymer Powder Free Examination Gloves | Grand Work Plastic Products Co., Ltd. | 2014-12-05 | 100 | 0 |
| K102089 | GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATI | Grand Work Plastic Products Co., Ltd. | 2010-10-06 | 62 | 0 |
| K102094 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES | Grand Work Plastic Products Co., Ltd. | 2010-10-05 | 61 | 0 |
| K061562 | VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR | Grand Work Plastic Products Co., Ltd. | 2006-07-11 | 36 | 0 |
| K051662 | VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR | Grand Work Plastic Products Co., Ltd. | 2005-07-22 | 30 | 0 |
| K042830 | POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES | Grand Work Plastic Products Co., Ltd. | 2004-11-17 | 35 | 0 |
| K040682 | SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE | Grand Work Plastic Products Co., Ltd. | 2004-07-28 | 134 | 0 |
| K041225 | SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES-POWERED | Grand Work Plastic Products Co., Ltd. | 2004-07-15 | 66 | 0 |
| K040681 | SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FR | Grand Work Plastic Products Co., Ltd. | 2004-06-03 | 79 | 0 |
| K041188 | GRAND WORK PLASTICS PRODUCTS CO., LTD., SYNTHETIC VINYL PATI | Grand Work Plastic Products Co., Ltd. | 2004-06-01 | 26 | 0 |
| K040702 | SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER | Grand Work Plastic Products Co., Ltd. | 2004-04-27 | 41 | 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