← Product Code [LZA](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LZA) · K020868 # CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE) (K020868) _Seal Polymer Industries Bhd. · LZA · Apr 22, 2002 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LZA/K020868 ## Device Facts - **Applicant:** Seal Polymer Industries Bhd. - **Product Code:** [LZA](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LZA.md) - **Decision Date:** Apr 22, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment. ## Device Story Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves are protective barriers worn by healthcare personnel. The gloves are designed to prevent cross-contamination between the wearer and the patient's body, fluids, waste, or environment. They are used in clinical settings by healthcare staff. The device functions as a physical barrier; it is manufactured from nitrile material. The gloves are provided non-sterile and are powder-free to reduce potential irritation. The healthcare provider wears the gloves during patient examinations or procedures to maintain hygiene and infection control standards. ## Clinical Evidence Bench testing only. Performance data demonstrates compliance with ASTM D6319-00 and FDA 1000 ml watertight test. Results: Watertight (AQL 2.5%), tensile strength (15.2 MPa before aging, 19.7 MPa after aging), ultimate elongation (670% before aging, 760% after aging), and powder content (<2mg/glove). Biocompatibility testing (Primary Dermal Irritation and Guinea Pig Sensitization) passed. ## Technological Characteristics Nitrile material; powder-free (<2mg/glove); dimensions: 240mm minimum length, varying palm widths; thickness: 0.10mm minimum (finger and palm). Meets ASTM D6319-00 standards. Non-sterile. ## Regulatory Identification A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # APR 2 2 2002 K 020868 SEAL POLYMER INDUSTRIES SDN. BHD. Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300 | 1.0 | SMDA 510 (K) SUMMARY | | |-----|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------| | 2.0 | Submitter | SEAL POLYMER INDUSTRIES SDN BHD
Lot 72706, Jalan Lahat
Kawasan Perindustrian Bukit Merah
31500 Lahat, Perak, Malaysia | | | Tel | (60 5) 322 3200 | | | Fax | (60 5) 322 2300 | | | Name of Contact Person | Ms. CHUN CHOOI FONG | | | Date of Summary Prepared | 14th January 2002 | | 3.0 | Name of Device | | | | Trade Name | Cashmere Non-Sterile, Powder Free Nitrile
Examination Gloves (White) | | | Common Name | Exam Glove | | | Classification Name | Nitrile Patient Examination Glove | ### 4.0 Identification of the Legally Marketed Devices Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00 and FDA requirements. #### 5.0 Description of The Device Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00 and FDA Water Leak Test. #### 6.0 The Intended Use of Glove A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment. > Page 1 of 3 ATTACHMENT L {1}------------------------------------------------ ### SEAL POLYMER INDUSTRIES SDN. BHD. Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 -- 322 3200, Fax : 605 -- 322 2300 ### 7. Summary of Performance Data: Performance data of gloves based on ASTM D6319-00 and FDA 1000 ml watertight test. | TEST | ASTM D6319-00 | CASHMERE POWDER
FREE NITRILE EXAM
GLOVES | |-------------------------------------|----------------|------------------------------------------------| | 1. Watertight (1000 ml) | GI
AQL=2.5% | Pass GI
AQL=2.5% | | 2. Length (mm) | | | | Size
XS | Min 230 | 240 mm minimum for
all sizes | | S | Min 230 | | | M | Min 230 | | | L | Min 230 | | | XL | Min 230 | | | 3. Palm width (mm) | | | | Size
XS | - | <80 | | S | 80 +/- 10 | 82 - 88 | | M | 95 +/- 10 | 92 - 98 | | L | 111 +/- 10 | 102-108 | | XL | - | >110 | | 4. Thickness (mm)
(Single Layer) | | | | Finger | Min 0.08 | 0.10 minimum | | Palm | Min 0.08 | 0.10 minimum | | 5. Physical Properties | | | | Before Aging | | | | Tensile Strength (Mpa) | Min 14.0 | 15.2 | | Ultimate Elongation (%) | Min 500 | 670 | | After Aging | | | | Tensile Strength (Mpa) | Min 14.0 | 19.7 | | Ultimate Elongation (%) | Min 400 | 760 | | 6. Powder Content | - | Below 2mg / glove | Page 2 of 3 ATTACHMENT L {2}------------------------------------------------ ### SEAL POLYMER INDUSTRIES SDN. BHD. Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300 - 8. The performance data of the glove as showed above meet the ASTM D6319-00 Standard and FDA's requirement. Powder content is below 2mg per glove, which meet the FDA Requirements. - 9. The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests. #### 10. Conclusion We concluded that the Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves meet: - -ASTM D6319-00 Standard - FDA pinhole requirements - - FDA minimum powder residual content ・ Page 3 of 3 ATTACHMENT L {3}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # APR 2 2 2002 Mr. Chun Chooi Fong Quality Assurance Department Manager Seal Polymer Industries Sdn. Bhd. LT 72706. Jalan Lahat, Kawasan Perindustrian Bukit Merah Lahat, Ipoh, Perak, MALAYSIA 31500 Re: K020868 Trade/Device Name: Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (White) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: March 13, 2002 Received: March 18, 2002 Dear Mr. Fong: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {4}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Timothý Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health {5}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT : Seal Polymer Industries Sdn. Bhd. Applicant Ko20868 510(K) Number : Device Name : Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (White) Indication For Use: This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, -. > .............................................................................................................................................................................. Concurrence of CDRH Office of Device Evaluation (ODC) Prescription Use: ... ... ... ... ... ...... Per 21 CFR 80.109 OR Over-The-Counter ... ... ... ... ....... Qian S. Lin (Division Sign-Off) (Division of Dental, Infection Control, Division ral Hospital Devices 510(k) Number -- --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LZA/K020868](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LZA/K020868) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com