510(k) Report

FDA applicant

Shield Gloves Manufacturer (M) Sdn Bhd

Crofton, MD18 decisions1994–20011 recall

FDA records 18 decisions for Shield Gloves Manufacturer (M) Sdn Bhd (Crofton, MD) from 1994 to 2001: 18 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer Patient Examination Glove). Its devices cite 1 predicate, 1 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 Shield Gloves Manufacturer (M) Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shield Gloves Manufacturer (M) Sdn Bhd since 2007.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Shield Gloves Manufacturer (M) Sdn Bhd by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LYYLatex Patient Examination Glove15decisions
  • LZAPolymer Patient Examination Glove3decisions

Who builds on its devices?

Later devices cite its devices 4 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K943807Royal Shield Pink Colored Non-Sterile Latex Examination GloveShield Gloves Manufacturer (M) Sdn Bhd · 19942cite it
  • K953496Royal Shield Non-Sterile Powder-Free Hypoallergenic Latex Examination GlovesShield Gloves Manufacturer (M) Sdn Bhd · 19951cites it
  • K000156Smart Shield Non-Sterile Powder-Free Peppermint Scented Green Latex Examination GlovesShield Gloves Manufacturer (M) Sdn Bhd · 20001cites it

What has FDA decided for it lately?

  • K011613Powder-Free Green Barrier-Pro Synthetic Butadiene Copolymer Examination GloveShield Gloves Manufacturer (M) Sdn Bhd · 2001
  • K000217Royal Shield Non-Sterile Purple (Pink/Blue) Colored Powdered Latex Exam with Protein Labeling Claim [<200…Shield Gloves Manufacturer (M) Sdn Bhd · 2000
  • K000156Smart Shield Non-Sterile Powder-Free Peppermint Scented Green Latex Examination GlovesShield Gloves Manufacturer (M) Sdn Bhd · 2000
  • K992418Royal Shield Non-Sterile Pink Colored Powdered Latex Examination Glove with and Without Strawberry Scent and…Shield Gloves Manufacturer (M) Sdn Bhd · 1999
  • K992419Royal Shield Non-Sterile Blue Colored Powdered Latex Examination Glove with Protein Content Labeling Claim…Shield Gloves Manufacturer (M) Sdn Bhd · 1999
  • K992417Royal Shield Non-Sterile Powdered Latex Examination Gloves (Protein Labeling Claim) 200 MCGM or Less of…Shield Gloves Manufacturer (M) Sdn Bhd · 1999
  • K991743Royal Shield Non-Sterile Bubble Gum Scented Powder-Free Latex Examination Glove with Protein Content…Shield Gloves Manufacturer (M) Sdn Bhd · 19991 recall
  • K991744Smart Shield Non-Sterile Powder-Free, Blue Nitrile Examination Gloves with Bubblegum ScentShield Gloves Manufacturer (M) Sdn Bhd · 1999

All 18 as Shield Gloves Manufacturer (M) Sdn Bhd →

What has been recalled?

1 recall linked to its devices; the latest:

  • K991743AU480 Chemistry Analyzers, Reference No. B28624 The AU series are automated, clinical…Jul 30, 2015Class II

Other applicant names beginning “Shield”

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

Shield Diagnostics, Ltd. 27Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. 5Shield Laboratories, Inc. 2Shield Gloves Medical Products Sdn Bhd 1Shield Computers, Ltd. 1