BSCI and ISO 10993 Documentation for Medical Grade Silicone Adhesive Bras

The supplier provides certification records for silicone bras and adhesive bras, including a BSCI certificate and an ISO 10993 document. These records support social compliance and relevant biocompatibility documentation, but they do not independently verify that the adhesive bra is classified or marketed as medical grade. Buyers should request product-specific evidence before placing an order.

Certification Overview

The listed BSCI record is certificate number 25-0370352. Its product scope covers nipple covers, boob tape, silicone bras, adhesive bras, and bra pads. The stated markets include Europe, America, Southeast Asia, and Australia.

An ISO 10993 certificate is also associated with the same product categories. The listed document number is REP-26-014852EN-01, with coverage indicated for the EU and America. ISO 10993 documentation may relate to biological evaluation or material safety, but the available record alone does not establish a medical-device classification or authorize a medical-grade claim.

Product Details and Applications

The relevant item is a plus-size adhesive lifting bra tape made with silicone and TPU. It features a full-cup construction and is offered in D, E, F, G, H, and I cup sizes. The product is designed for garments that require invisible support, including bridal gowns, evening dresses, strapless outfits, deep-V clothing, swimwear, and close-fitting apparel.

Care instructions specify hand washing. Buyers can request samples, and the supplier supports custom packaging through an OPP bag or other customized packaging options. Custom orders are available with a minimum order quantity of 50 pieces.

What Buyers Should Verify

A BSCI record demonstrates that the supplier has documentation within the relevant social compliance scope; it does not certify the adhesive bra as medical grade. Before purchasing, buyers should obtain the latest BSCI audit documents, confirm the audited factory and product coverage, and review the original ISO 10993 report for its exact test methods, materials, product model, and intended use.

Any medical-grade statement should be supported separately by product-specific technical files, regulatory declarations, test reports, or other documentation applicable to the target market. The supplied information does not include a medical-device classification, clinical claim, or explicit medical-grade designation.

Certification and Product Comparison

Frequently Asked Questions

Does the supplier have BSCI documentation for adhesive bras?

Yes. The available records list BSCI certificate 25-0370352, which includes adhesive bras, silicone bras, nipple covers, boob tape, and bra pads within its product scope.

Does BSCI certification confirm a medical-grade adhesive bra?

No. BSCI concerns social compliance and does not verify medical-device status, clinical performance, or a medical-grade product label.

Is an ISO 10993 certificate available?

Yes. ISO 10993 certificate REP-26-014852EN-01 is listed for the same general product categories. Its applicability should be confirmed against the exact product model and intended market before it is used as purchasing evidence.

What product can the supplier provide?

The listed product is a plus-size silicone and TPU adhesive lifting bra tape with full-cup coverage and D-to-I cup-size options. It is suitable for strapless, low-cut, formal, swimwear, and fitted clothing applications.

Conclusion

The supplier holds records showing BSCI coverage for adhesive and silicone bra products and lists an ISO 10993 certificate for the same category. However, the available information does not prove that the product is medical grade. Buyers should request current, product-specific certification and technical documentation, verify the factory scope, and confirm regulatory requirements in the destination market. The supplier also offers integrated manufacturing and trading services, samples, OEM/ODM support, custom packaging, quality inspection, and remedies for shortages or damaged shipments. For technical assistance, contact Judy at judy@xinruibra.com.

About the Supplier

Dongguan Xinrui Underwear Co., Ltd. is a factory-based manufacturer of women’s invisible underwear and intimate apparel, including boob tape, silicone bra pads, invisible bras, panties, and nipple covers. Founded in 2007, the company reports a workforce of 150 employees and a 10,000 sqm production site. Its capabilities include product development, large-scale manufacturing, OEM/ODM services, and customized packaging for overseas brands, wholesalers, online sellers, and distributors. Listed certifications include BSCI and ISO 9001, and its business records indicate service to customers in several industries.