Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shanghai Palomar Mountain Industries, Inc. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
81 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K031142 | DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR | Shanghai Palomar Mountain Industries, Inc. | 2004-03-17 | 195 | 0 |
| K031072 | DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN E | Shanghai Palomar Mountain Industries, Inc. | 2003-05-06 | 32 | 0 |
| K030094 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE | Shanghai Palomar Mountain Industries, Inc. | 2003-04-01 | 81 | 0 |
| K030148 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COL | Shanghai Palomar Mountain Industries, Inc. | 2003-02-19 | 35 | 0 |
| K023560 | ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDERED | Shanghai Palomar Mountain Industries, Inc. | 2002-12-17 | 55 | 0 |
| K023343 | ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED | Shanghai Palomar Mountain Industries, Inc. | 2002-10-28 | 21 | 0 |
| K992100 | PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDE | Shanghai Palomar Mountain Industries, Inc. | 1999-07-29 | 38 | 0 |
| K991457 | DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE | Shanghai Palomar Mountain Industries, Inc. | 1999-07-01 | 66 | 0 |
| K990267 | POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVES | Shanghai Palomar Mountain Industries, Inc. | 1999-03-29 | 60 | 0 |
| K990299 | POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVE | Shanghai Palomar Mountain Industries, Inc. | 1999-03-29 | 56 | 0 |
| K990081 | DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDERED | Shanghai Palomar Mountain Industries, Inc. | 1999-02-19 | 39 | 0 |
| K990117 | DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE | Shanghai Palomar Mountain Industries, Inc. | 1999-02-19 | 37 | 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