510(k) Report

FDA applicant

Safehealth Labs

Allendale, NJ1 decision1991–19910 recalls

FDA records 1 decision for Safehealth Labs (Allendale, NJ) in 1991: 1 510(k) clearance. All are in product code LYY (Latex Patient Examination Glove). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Safehealth Labs’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Safehealth Labs since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Safehealth Labs by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Safehealth Labs’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Safehealth”

FDA records each applicant name separately; these may or may not be the same firm.