Import 3-Ply Disposable Mask For Kid With Fda — Buy in wholesale FOB from Supplier in China

This paediatric 3-ply disposable mask from Dongguan Puji Medical Technology Co, Ltd. is engineered for children and complies with T/CTCA 7-2019, the Chinese textile industry standard for disposable protective masks, supplemented by FDA registration for the US market. The construction employs SMS (spunbond-meltblown-spunbond) non-woven polypropylene fabric, a material format common in medical-grade disposables where the melt-blown core provides filtration and the spunbond skins contribute tear resistance and moisture management. The child-specific model (PJ&SM-01) is available in multiple colours rather than the blue/white restriction of the adult variant, with packaging of 50 pieces per bag and 1,000 pieces per carton at identical 6 kg/7 kg net/gross weights. Box dimensions of 170 by 98 by 75 mm reflect the smaller folded profile required for child-sized facial coverage.

T/CTCA 7-2019 specifies technical requirements for single-use protective masks including filtration efficiency, breathing resistance, and strap tensile strength, though it is less widely recognised internationally than GB/T32610-2016 or EN 149. The SMS fabric construction typically achieves 15-25 GSM for each spunbond layer and 20-25 GSM for the melt-blown core in child masks, with overall lighter basis weight than adult equivalents to accommodate lower tidal volumes and smaller facial geometry. Multi-colour availability suggests dyeing or pigmentation of the outer spunbond layer, which requires verification of colourfastness and absence of azo dyes or heavy metals for child safety compliance in regulated markets. The FDA registration cited does not denote 510(k) clearance for medical use unless explicitly stated, a distinction critical for buyers supplying hospitals versus retail or educational settings.

Primary buyers include paediatric healthcare providers, school district procurement officers, childcare facility managers, and retail distributors of children's health products. The smaller carton dimensions of 520 by 355 by 180 mm versus the adult variant allow denser container loading, potentially reducing per-unit freight cost for importers. Child mask sizing typically targets age ranges of 4-12 years, though the supplier does not specify age banding or dimensional grading. Importers must confirm whether the product is marketed as a medical device or general wellness item, as this governs regulatory pathways in target markets. Direct engagement with the supplier is necessary to establish current MOQ, lead time, available colour SKUs, and whether lot-specific testing documentation is provided.

Dongguan Puji Medical Technology Co, Ltd. is located at No. 388 Santang Road, Gaobu Town, Dongguan City, Guangdong Province, China 523000, in the Pearl River Delta manufacturing region. The supplier maintains a harbor trust tier with zero recorded response rate and zero average response hours, indicating no platform-mediated communication history is available. The company operates the Puji brand across both adult and paediatric disposable mask SKUs, with shared model numbering (PJ&SM-01) suggesting unified production lines or product family grouping rather than distinct manufacturing facilities.

The supplier's profile indicates ISO 13485 certification for factory operations and FDA registration for both adult and child mask products, though no details are provided regarding factory establishment year, production floor area, employee count, annual capacity, export percentage, or named reference customers. The absence of response metrics means buyers cannot assess quotation speed or communication reliability through platform data alone. Direct due diligence, including factory audit or video verification, is advisable before committing to volume orders, particularly for child-specific products subject to heightened safety scrutiny in destination markets.