Disposable cleanroom protective garments are designed for use in phamaceutical cleanrooms ranging from ISO Class 4 to Class 8,supporting both sterile and non-sterile GMPenvironments.These products are manufactured and tested in strict accor- dance with the IEST-RP-CC003.4 standard,ensuring compliance with particle-shedding requirements for Category I,Il,andII cleanroom apparel.Each garment meets the cleanliness specifications appropriate to its classification,providing reliable contam- ination control across various cleanroom applications.
● Our quality management system is fully compliant with ISO 9001:2016 and ISO 13485:2016 standards,ensuring consistent and reliable operations.
● Each product batch is accompanied by a Certificate of Conformance(CoC)and a sterility report to verify product integrity and safety.
● Cleanliness levels are validated for every batch using the Helmke Drum Test,in accordance with the best industrial practices.
● On-site audits can be arranged upon customer request to provide transparency and confidence in our processes.
● Comprehensive quality documentation is available to customers upon request,supporting regulatory and internal compliance needs.
● All stages of production,processing,and sterilization are fully traceable,ensuring accountability and end-to-end quality control.
● Our quality management system is fully compliant with ISO 9001:2016 and ISO 13485:2016 standards,ensuring consistent and reliable operations.
● Each product batch is accompanied by a Certificate of Conformance(CoC)and a sterility report to verify product integrity and safety.
● Cleanliness levels are validated for every batch using the Helmke Drum Test,in accordance with the best industrial practices.
● On-site audits can be arranged upon customer request to provide transparency and confidence in our processes.
● Comprehensive quality documentation is available to customers upon request,supporting regulatory and internal compliance needs.
● All stages of production,processing,and sterilization are fully traceable,ensuring accountability and end-to-end quality control.
| Description | SKU | Sterile | Fabrics | Classification |
|---|---|---|---|---|
| Coverall with hoodand integrated boots/- four-thread sewing/elastic cuff&ankle/thumb ring/sterile folding/cleanroom production and packaging. | K5F4 | Y | F | ISO 5/6;GMPA/B |
| K5M4 | Y | M | ISO 5/6;GMPA/B | |
| K5P4 | Y | P | ISO 5/6;GMPA/B | |
| K7F4 | Y | F | ISO 7;GMPC | |
| K7P4 | Y | P | ISO 7;GMPC | |
| K8M4 | N | M | ISO 8;GMPD | |
| Coverall without hood and integrated boots/- four-thread sewing/elastic cuff&ankle/thumb ring/sterile folding/cleanroom production and packaging | K5F2 | Y | F | ISO5/6;GMPA/B |
| K5P2 | Y | P | ISO5/6;GMPA/B | |
| K5M2 | Y | M | ISO5/6;GMPA/B | |
| Coverall with hood/four-thread sewing/elastic cuff&ankle/thumbring/sterile folding/clean- room production and packaging | K7P3 | Y | P | ISO 7;GMPC |
| K8M3 | N | M | ISO8;GMPD | |
| Cleanroomhood,bound sewing/sterile fold- ing/cleanroom production and packaging | K5FH | Y | F | ISO5/6;GMPA/B |
| K5PH | Y | P | ISO5/6;GMPA/B | |
| K5MH | Y | M | ISO5/6;GMPA/B | |
| Cleanroom boot covers,bound sewing/sterile folding/cleanroom production and packaging | K5FB | Y | F | ISO 5/6;GMPA/B |
| K5PB | Y | P | ISO 5/6;GMPA/B | |
| K5MB | Y | M | ISO5/6;GMPA/B | |
| K7PB | Y | P | ISO 7;GMPC | |
| K8MB | N | M | ISO 8;GMPD | |
| Cleanroom oversleeves,bound sewing/sterile folding/cleanroom production and packaging | K5FO | Y | F | ISO5/6;GMPA/B |
| K5PO | Y | P | ISO5/6;GMPA/B | |
| Cleanroom apron,bound sewing/sterile fold- ing/cleanroom production and packaging | K7PA | Y | P | ISO 7;GMPC |
| K7PAS | Y | P | ISO 7;GMPC | |
| Cleanroom lab coat,excellent anti-liquid sprayingperformance/Reinforced bound sew- ing/elastic cuffs and ankles/front zipper/collar design/sterile folding/cleanroom production and packaging | K7PC | Y | P | I SO 7;GMPC |
※ When choosing a product,please refer to the product code explanation:
·K5=ISO 5/6; GMP A/B
·M=SMS fabric
·B=Non slip boot cover
·2=Coverall without hood and boots
·K7=ISO 7; GMP C
·P=Microporous breathablefilm fabric
·H=Hood
·3=Coverall with hood
·K8=ISO 8 ; GMP D
·F=spolek™flash spinning fabric
·0=Oversleeves
·4=Coverll with hood and boots integrated
We are a professional manufacturer of protective clothing, so we can offer you factory direct prices.
Yes, we can accept OEM. We can design product and package based on your requirement.
It's no problem if you have small quantity, we would like to grow up with you together.
Please give me the exactly specification, So we can give you samples.
