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

This 3-ply disposable mask for adults is manufactured by Dongguan Puji Medical Technology Co, Ltd. in Dongguan City, Guangdong Province, China, and carries FDA registration alongside GB/T32610-2016 standard compliance. The mask uses a layered construction of non-woven polypropylene (PP) outer and inner layers with a melt-blown fabric middle layer, the standard configuration for mechanical and electrostatic filtration in disposable respiratory PPE. Each unit is produced under ISO 13485 certified quality management conditions, a baseline requirement for medical device manufacturing in China. The adult model (PJ&SM-01) is packed 50 pieces per bag, 20 bags per carton, yielding 1,000 masks per carton with a gross weight of 7 kg and net weight of 6 kg.

The GB/T32610-2016 standard specifies daily protective masks with filtration efficiency requirements against non-oil particulate matter, distinct from surgical mask standards (YY/T 0469) or respirator standards (GB 2626/KN95). The melt-blown layer typically achieves 20-30 gram per square metre (GSM) basis weight in standard 3-ply construction, with BFE (bacterial filtration efficiency) commonly tested at 3.0 micrometres. The non-woven PP layers provide structural integrity and moisture wicking, while the middle layer performs the primary mechanical filtration. Colour options of blue or white are standard for medical and general protective environments, with blue the conventional clinical choice to distinguish from surgical-grade masks.

Adult sizing suits face widths of approximately 175 mm by 95 mm, the typical unfolded dimension for adult disposable masks in East Asian manufacture. Buyers include healthcare procurement departments, workplace safety distributors, hospitality chains, and government stockpile managers. The carton dimensions of 540 by 405 by 180 mm suit standard palletisation for sea freight. Importers should verify current FDA registration status and 510(k) applicability for intended medical use, as GB/T32610-2016 compliance alone does not confer US medical device clearance. Bulk minimum order quantities and specific Incoterms require direct confirmation with the supplier, as these trade terms are not stated in the listing data.

Dongguan Puji Medical Technology Co, Ltd. operates from No. 388 Santang Road, Gaobu Town, Dongguan City, Guangdong Province, China 523000. The company holds a harbor trust tier on the platform, with a response rate of 0.00 percent and average response hours recorded at zero, indicating no response data is currently available through platform tracking. The supplier lists ISO 13485 certification for its factory quality management system and manufactures under the brand name Puji with model designation PJ&SM-01 for its product line.

The supplier's listed product focus is disposable protective masks for adult and paediatric markets, with FDA registration cited for both product categories. No information is provided regarding year of establishment, factory floor area, headcount, annual output capacity, export revenue, or named clientele. The response data absence means buyers should expect to initiate direct contact to assess communication reliability and quotation turnaround. The Dongguan location places manufacturing within the Pearl River Delta manufacturing cluster, with access to Shenzhen Port and Hong Kong for international freight forwarding.