Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Hong Huang Tang Industrial Co., Ltd. · Predicate Candidate Screening

3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K034060DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHong Huang Tang Industrial Co., Ltd.2004-02-06370
K974334DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVESHong Huang Tang Industrial Co., Ltd.1998-01-09520
K962026PREPOWDER VINYL PATIENT EXAMINATION GLOVESHong Huang Tang Industrial Co., Ltd.1996-09-101100

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