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medrainbow@gmail.com
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No. 20, Zijing Road, Suchen Town, Taizhou, Jiangsu, China
Home/Quality

The papers behind the product.

Buyers rarely lose an order over a sample. They lose it over a certificate that does not cover their market, or a sterility record nobody can produce. Everything on this page exists to answer those two questions.

Production flow

From raw cotton to a sealed carton.

Eight stations, one site. Nothing is subcontracted, so a batch never leaves our records — and a correction is made in our building, not someone else's.

  1. 01

    Raw material intake

    Cotton, gauze, non-woven and resin checked against the approved sample; gram weight, absorbency and whiteness logged before the batch is accepted.

  2. 02

    Slitting & converting

    Rolls cut to width in the dust-free workshop, with the machine record kept against the batch number.

  3. 03

    Forming & impregnation

    Cotton rolls, gauze plies and scrub brushes formed and impregnated — dry, 4% CHG or 7.5–10% iodophor.

  4. 04

    Kit assembly

    Components counted into the tray against your content list, then sealed in the pouch printed with your artwork.

  5. 05

    EO sterilization

    On-site ethylene oxide sterilization workshop, cycles run in-house with parametric release recorded per load.

  6. 06

    Aeration & lab release

    Residue aeration, then bioburden and sterility testing in our own microbiology laboratory.

  7. 07

    Outer packing

    Cartons marked to your instruction, quantity and gross weight verified against the proforma invoice.

  8. 08

    Warehouse & loading

    Palletised in the finished-goods warehouse, photographed before the container is sealed.

Every station keeps a record. Batch numbers run from raw material to carton, so a sterility query on a shipment from two years ago can still be traced back to the load and the test result.

Certificates

The marks behind every quotation.

Scanned copies are sent with every quotation. Originals are available for inspection at the plant or notarised on request.

ISO 13485:2016Quality management

Certified medical device quality management system covering production at the Taizhou site.

ISO 11135:2014EO sterilization

The standard the 800 m² ethylene oxide room runs to, with a record kept per sterilization cycle.

CEEuropean market

Declaration of conformity issued per product family for European distribution.

FDAUS documentation

Establishment registration and device listing documentation, released to qualified buyers.

SGSAudited supplier

Third-party audited supplier file held on the SGS verification platform.

SGS audited supplier19 years on Alibaba.comExports to 110+ countriesIn-house EO sterilization
In-house

Sterility that never leaves the building.

In-house EO sterilization

Ethylene oxide cycles run on site with parametric release records kept per batch — no third-party sterilizer in the chain.

Microbiology laboratory

Bioburden, sterility and absorbency testing before release, with the raw data retained and available on audit.

Batch retention

Every shipment keeps a retained sample and its inspection record, so a reorder can be matched to the original specification years later.

Control points

Four checks between cotton and container.

1

Incoming material

Gram weight, absorbency and whiteness verified against the approved sample before the batch is accepted.

2

In-line

Seal strength, count and label position checked at fixed intervals through each shift.

3

Sterility release

Laboratory release before packing; a batch does not ship on a verbal OK.

4

Pre-shipment

Carton marks, quantity and shipping documents verified against the proforma invoice before the container is sealed.

On the floor

What the checks look like.

Photographs from the clean room, the converting line and the packing stations — the same rooms an auditor walks through.

Operators running the packing machine in sterile gowns
Packing lineCount, seal strength and label position checked every shift, against the approved sample.
View through the window into the Class 100,000 clean workshop
Clean workshopClass 100,000, gowned entry — the room an auditor walks through before seeing a single document.
Packing & shipping

Cartons photographed before the container is sealed.

Packing is where most claims are born — crushed cartons, short counts, marks that do not match the destination. We photograph the load and send the images with the shipping documents.

Palletised export cartons in the finished-goods warehouse
Finished goodsCartons marked to your instruction
Rows of shrink-wrapped pallets waiting for loading
PalletisedWrapped and labelled per pallet plan
Export cartons of surgical scrub brushes strapped for shipment
Export cartonsStrapped and marked for the container
Warehouse aisle with packed export cartons
WarehouseBatch-labelled and traceable
Wooden crates and cartons on pallets ready to load
Crated ordersFor lines that need extra protection
Forklift loading cartons into a shipping container
Container loadingPhotographed before sealing

Packing

Polybag, pouch or display carton — sized so the goods survive the last mile, not just the sea freight. Carton dimensions and gross weight go on the packing list.

Transport

Sea freight FOB or CIF from Shanghai and Ningbo, air freight for samples and urgent lines, and express for small repeat orders.

Documents

COA, MSDS, certificate of origin and packing list issued with the shipment; CE declaration of conformity where the line requires it.

Document set

What ships with every order.

Not offered on request — issued as part of the shipping documents.

  • Certificate of analysis (COA) per batch
  • Material safety data sheet (MSDS)
  • Certificate of origin for customs
  • CE declaration of conformity where applicable
  • Packing list with carton dimensions and gross weight
Rich Medical production base
QUALITY SYSTEMISO 13485

Need the paperwork for your market?

Send the destination and product line — we will confirm in writing which certificates apply before you order.