510(k) Report

FDA applicant

Tangshan Zhonghong Pulin Plastic Co.,Ltd

Beijing, CN2 decisions2012–20121 recall

FDA records 2 decisions for Tangshan Zhonghong Pulin Plastic Co.,Ltd (Beijing, CN) in 2012: 2 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYZ (Vinyl Patient Examination Glove). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 Tangshan Zhonghong Pulin Plastic Co.,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2012: 2
2012high 2 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2012high 1 (2016) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Tangshan Zhonghong Pulin Plastic Co.,Ltd by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Tangshan”

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