BSCI and ISO 10993 Documentation for Medical Grade Silicone Adhesive Bras

Certification Status for Silicone Adhesive Bras

The supplier has provided certification records covering silicone bras, adhesive bras, nipple covers, boob tape, and bra pads. The available documentation includes a BSCI certificate and an ISO 10993 certificate for these product categories. However, the records do not independently verify that the adhesive bra is formally classified or marketed as a medical-grade product.

Key Findings for Buyers

• BSCI certificate number 25-0370352 lists silicone bras, adhesive bras, nipple covers, boob tape, and bra pads within its product scope.
• ISO 10993 certificate number REP-26-014852EN-01 is also associated with the same product categories.
• ISO 10993 documentation alone does not establish a legal medical-device classification or confirm a medical-grade claim.
• The referenced product is a plus-size, full-cup adhesive lifting bra made with silicone and TPU.
• Available sizes cover D, E, F, G, H, and I cups, making the product suitable for larger-size applications.

Certification and Product Scope

BSCI Audit Documentation

The supplier's social compliance record is identified as BSCI certificate 25-0370352. Its listed scope includes nipple covers, boob tape, silicone bras, adhesive bras, and bra pads. The coverage information refers to sales or application regions including Europe, America, Southeast Asia, and Australia.

ISO 10993 Record

The supplied company data also lists ISO 10993 certificate REP-26-014852EN-01 for the related product categories, with the EU and America identified as applicable regions. This supports the existence of an ISO 10993 record, but the certificate should be reviewed to confirm the tested product, test methods, intended use, and validity period. It should not be treated as proof of medical-grade status without additional product-specific evidence.

Product Details and Customization

The listed item is a full-cup adhesive lifting bra tape manufactured from silicone and TPU. It is designed for D through I cup sizes and can be used with bridal gowns, evening dresses, strapless outfits, deep-V clothing, swimwear, and close-fitting garments. The product requires hand washing for care.

For private-label and wholesale orders, the supplier offers samples, custom packaging, and an OPP bag packaging option. Custom orders are listed with a minimum order quantity of 50 pieces. Buyers should confirm final specifications, adhesive performance, packaging details, and production terms before approval.

What Buyers Should Verify

Before placing an order, buyers should request the latest BSCI audit documentation and confirm that it applies to the actual manufacturing site and the intended product scope. They should also ask for the complete ISO 10993 report or certificate, including the product name, tested materials, test results, issuing body, and expiration information.

If the supplier uses the term “medical grade,” the buyer should request separate supporting evidence, such as a product-specific technical file, regulatory classification, labeling basis, or market authorization where applicable. The current records confirm certification references, but they do not establish a clinical claim or medical-device designation for the adhesive bra.

Verification Summary

Frequently Asked Questions

Does the supplier have a BSCI record for adhesive bras?

Yes. The supplied information identifies BSCI certificate 25-0370352, which covers adhesive bras and related products such as silicone bras, nipple covers, boob tape, and bra pads.

Does BSCI certification confirm that the product is medical grade?

No. BSCI concerns social compliance and responsible business practices. It does not verify medical-device status, clinical performance, or a medical-grade product classification.

Is ISO 10993 evidence available?

Yes. ISO 10993 certificate REP-26-014852EN-01 is listed for the relevant product categories. The buyer should confirm the exact scope and whether the document applies directly to the finished adhesive bra being purchased.

What product is covered by the available information?

The referenced product is a silicone and TPU full-cup adhesive lifting bra tape available for D to I cup sizes. It is intended for use with strapless, low-cut, formal, swimwear, and fitted clothing.

Conclusion

The available records indicate that the supplier has BSCI documentation for silicone bras and adhesive bras, together with an ISO 10993 certificate listing the same general product categories. The product information describes a full-cup silicone and TPU adhesive lifting bra for plus-size users, with samples, custom packaging, and a listed custom MOQ of 50 pieces.

These records do not, however, prove that the adhesive bra is medical grade. Buyers should obtain current certificates, verify the factory and product scope, and request separate regulatory or technical evidence for any medical-grade claim. The supplier also provides integrated manufacturing and trading services, quality inspection support, and remedies for issues such as short shipments or damaged goods. For product inquiries, contact Judy at judy@xinruibra.com.

About the Supplier

Dongguan Xinrui Underwear Co., Ltd. is a factory-based manufacturer and supplier of women's invisible underwear and intimate apparel. Its product range includes boob tape, silicone bra pads, invisible bras, panties, and nipple covers. Founded in 2007, the company reports approximately 150 employees and a 10,000 sqm factory. Its services cover product development, OEM/ODM production, mass manufacturing, and customized packaging for overseas brands, wholesalers, e-commerce businesses, and distributors. Listed certifications include BSCI and ISO 9001.