Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sinochem (Usa), Inc. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
100 daysmedian FDA review time
100 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K900980 | LATEX EXAMINATION GLOVES | Sinochem (Usa), Inc. | 1990-06-01 | 91 | 0 |
| K901398 | LATEX SURGEON GLOVES | Sinochem (Usa), Inc. | 1990-05-16 | 51 | 0 |
| K900352 | LATEX EXAM GLOVES (SHANGHAI RONGTONG LATEX GLOVES) | Sinochem (Usa), Inc. | 1990-03-27 | 63 | 0 |
| K893882 | LATEX EXAMINATION GLOVES | Sinochem (Usa), Inc. | 1989-09-21 | 118 | 0 |
| K893694 | LATEX EXAM GLOVES(MFG: SHANG HAI RONGTONG LATEX) | Sinochem (Usa), Inc. | 1989-08-10 | 86 | 0 |
| K892153 | PATIENT EXAM GLOVES (MFG. JIANDE RUBBER PRODUCTS) | Sinochem (Usa), Inc. | 1989-07-14 | 100 | 0 |
| K892155 | PATIENT EXAM GLOVES (MFG. HUBEI TIANMEN LATEX) | Sinochem (Usa), Inc. | 1989-07-14 | 100 | 0 |
| K892158 | PATIENT EXAM GLOVES (MFG. SUZHOU LATEX FACTORY) | Sinochem (Usa), Inc. | 1989-07-14 | 100 | 0 |
| K892157 | PATIENT EXAM GLOVES (MFG. RONGCHENG LATEX PRODUCT) | Sinochem (Usa), Inc. | 1989-07-14 | 100 | 0 |
| K892156 | PATIENT EXAM GLOVES (MFG. NO. 1 FACTORY, WUHAN) | Sinochem (Usa), Inc. | 1989-07-14 | 100 | 0 |
| K892154 | PATIENT EXAM GLOVES (MFG. LIAONING FOREIGN TRADE) | Sinochem (Usa), Inc. | 1989-07-14 | 100 | 0 |
| K892151 | PATIENT EXAM GLOVES (MFG. GUILIN LATEX FACTORY) | Sinochem (Usa), Inc. | 1989-07-14 | 100 | 0 |
| K892159 | PATIENT EXAM GLOVES (MFG CHAOYANG SYNTHETIC FIBRE) | Sinochem (Usa), Inc. | 1989-07-14 | 100 | 0 |
| K892152 | PATIENT EXAM GLOVES (MFG. NINGBO MEDICAL LATEX) | Sinochem (Usa), Inc. | 1989-06-22 | 78 | 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