Medical Devices and PPE
S+P Glove is one of the world’s leading manufacturers & exporters of premium quality gloves specializing in OEM and private label. Our products are distributed to all major markets, including the USA, Europe, Latin America, and Asia. Our vast experience and expertise in life science and medical device manufacturing ensure that our gloves offer extreme comfort, strength, and tactility.
S+P medical gloves are certified internationally, including CE Marking and US FDA 510(k) clearance. We have developed a technologically advanced manufacturing process with high efficiency and flexibility, allowing us to create a variety of gloves.
At S+P Glove, we believe in high-quality products and excellent customer service. “Total Customer Satisfaction” is a motto we strive to achieve. Hence, our dynamic and dedicated personnel are committed to providing prompt responses at all times to meet our customers’ demands and earn their trust.
Through our ongoing research and development, we strive to meet and surpass the ever-changing market needs, expanding our capability and capacity to cater to more customers worldwide, reinforcing our status as one of the world’s leading medical glove suppliers!
We strive to improve and innovate beyond industry standards and customers’ expectations, setting greater benchmarks in the industry.
We supply products that meet or exceed the required standards while adhering to rigorous safety standards.
CERTIFICATION AND TEST REPORTS
BSI QUALITY MANAGEMENT SYSTEM
ISO 13485: 2016
ISO 9001: 2015
US FDA 510(K): K153732
ASTM D6319, ASTM D6978
CE and EN TEST CERTIFICATES
1. EN ISO 21420: 2020
2. EN16523-1: 2015-A1:2018
• CE and EN TEST CERTIFICATES 1. EN ISO 374-1:2016+A1:2018 2. EN 374-2:2019
3. EN374-4:2019
4. EN374-5:2016
• TUV Rhienland Test Reports
1. EN455-1, EN455-2
• EU Type-Examination Certificate Number: 2777
Produced for use in the health sector, our non-surgical isolation gowns provide a barrier to various levels of liquid penetration through splatter and exposure through soaking. Our high-quality gowns are all classified as AAMI levels 1, 2 & 3. Conforming to AAMI PB70:12 standards, our gowns have passed AATCC 42 and AATCC 127 standardized tests, measuring impact penetration and hydrostatic pressure.