510(k) Report

FDA applicant

Hebei Tengda Plastic Co., Ltd.

Shijiazhuang, CN2 decisions2011–20111 recall

FDA records 2 decisions for Hebei Tengda Plastic Co., Ltd. (Shijiazhuang, CN) in 2011: 2 510(k) clearances. All are in product code 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 Hebei Tengda Plastic Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2011: 2
2011high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2011high 1 (2012) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Hebei Tengda Plastic Co., Ltd. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hebei Tengda 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.

See the 510(k) Report

Which product codes does it file in?

  • LYZVinyl Patient Examination Glove2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K102152Powder-Free Vinyl Patient Examination GlovesHebei Tengda Plastic Co., Ltd. · 20111 recall
  • K102151Powdered Vinyl Patient Examination GlovesHebei Tengda Plastic Co., Ltd. · 2011

All 2 as Hebei Tengda Plastic Co., Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K102152Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large…Jun 20, 2012Class II