Quality & Compliance
Certification is listed per product line rather than pooled, because that is how a tender will read it.
Per line, not per company
The old site lists a different certification set against each product, and this rebuild keeps them separate. Nitrile examination glove: FDA-510K, ASTM D6319, EN455. Powder-free nitrile: FDA listing. Latex exam glove: CE. Vinyl exam glove: FDA. Syringe needle: CE, FDA, ANVISA. Pooling those into one badge wall would be misleading, so it has not been done.
The wholesale stock lines
The wholesale page adds further standards against the in-stock lines: ISO 10993, EN374, EN455 and EN420 with ASTM D6319 on nitrile; ISO 9001-2016, EN455, EN374 and EN16523 on blend nitrile; ISO 9001:13485 with EN455 and EN374 on vinyl — all listed as FDA / 510K / CE registered.
Third-party evidence
On masks, the old FAQ names SGS as the third-party body engaged to testify to legality and conformity, and points to the CDC International Respirator Assessment as the independent evaluation route for imported respirators. Ask for the SGS report by product line and date rather than for a generic certificate pack.
Products this applies to
Disposable Nitrile Examination Glove
The clinical default — FDA-510K, ASTM D6319 and EN455 on one glove
View product →
Disposable Syringe Needle
The only sterile line here — CE, FDA and ANVISA
View product →
Disposable Surgical Face Masks (3-ply, non-sterile)
Surgical grade — YY 0469-2011 and CE EN 14683, with splash resistance
View product →
Disposable Latex Exam Glove
Natural latex, CE marked — best fit and feel, at the allergy trade-off
View product →
Disposable Vinyl Exam Glove
The low-cost, silicon-free, antistatic option
View product →
Disposable Medical Face Masks (3-ply, non-sterile)
Medical grade — YY/T 0969-2013 and CE EN 14683
View product →Put it to work on your order
Name the capability you need and the product it applies to, and you will get a straight answer on what is possible and what it costs.