← Product Code [LYZ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ) · K041225 # SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES-POWERED (K041225) _Grand Work Plastic Products Co., Ltd. · LYZ · Jul 15, 2004 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K041225 ## Device Facts - **Applicant:** Grand Work Plastic Products Co., Ltd. - **Product Code:** [LYZ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ.md) - **Decision Date:** Jul 15, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use A patient examination glove is a disposable device intended for medical purposes that 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 Synthetic (Yellow) Vinyl Patient Examination Gloves (powdered) are disposable, single-use gloves worn by healthcare personnel. Device acts as a physical barrier to prevent contamination between the examiner and the patient's body, fluids, waste, or environment. Used in clinical or medical settings. No complex processing or electronic components; device is a passive barrier product. ## Clinical Evidence No clinical data. Bench testing only: physical and dimensions testing (ASTM D5250-00E4), water fill test for pinholes (ASTM D5151-99), and biocompatibility testing (primary skin irritation and sensitization). ## Technological Characteristics Material: Synthetic vinyl. Standards: ASTM D5250-00E4, ASTM D5151-99 (water fill), ASTM D6124-01 (residual powder). Form factor: Powdered patient examination glove. No electronic or software components. ## 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. ## Predicate Devices - Shijiazhuang Great Vision Plastic Products Co., Ltd. Powdered Vinyl Patient Examination Gloves (Yellow) ([K992862](/device/K992862.md)) ## 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}------------------------------------------------ ### 510(K) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 8807.92. | The assigned 510(k) number is: | K041225 | |--------------------------------|---------| |--------------------------------|---------| #### 1. Submitter's Identification: Mr. Shuangzu Ma Grand Work Plastics Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei Province P.R. China Date Summary Prepared: March 01, 2004 #### 2. Name of the Device: Grand Work Plastics Products Co., Ltd. Synthetic (Yellow) Vinyl Patient Examination Gloves—Powdered #### 3. Predicate Device Information: Shijiazhuang Great Vision Plastic Products Co., Ltd. Powdered Vinyl Patient Examination Gloves (Yellow) (K992862) #### 4. Device Description: Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powdered Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00E4. #### 5. Intended Use: A patient examination glove is a disposable device intended for medical purposes that 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. {1}------------------------------------------------ #### 6. Comparison to Predicate Devices: Grand Work Plastics Products Co., Ltd. Synthetic (Yellow) Vinyl Patient Examination Gloves-Powdered, is substantially equivalent in safety and effectiveness to the Shijiazhuang Vision Plastic Products Co., Ltd. Powdered Vinyl Patient Examination Gloves (Yellow). #### 7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows: The standards used for Grand Work Plastics Products Co., Ltd. glove production are based on ASTM-D-5250-00E4. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2. AOL 4.0. The FDA 1000 ml. Water Fill Test based on ASTM D-5151-99 was also conducted with samplings of AQL 2.5, Inspection Level I, meeting these requirements. Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions. There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels. A Residual Powder Test that based on ASTM D6124-01 for Starch at finished inspection is conducted to insure that our gloves meet our "powdered' claims (contain no more than 10 mg/dm2). #### 8. Discussion of Clinical Tests Performed: Not Applicable - There is no hypoallergenic Claim. #### 9. Conclusions: Grand Work Plastics Co., Ltd. Synthetic (Yellow) Vinyl Patient Examination gloves---- Powdered conform fully to ASTM-D-5250-00 €4 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo. The logo is circular and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle or bird with three curved lines representing its body and wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## JUL 1 5 2004 Grand Work Plastics Products Company Limited C/O Mr. James Chu Official Correspondent Gloveco, Incorporated 590 West Central Avenue, #D Brea, California 92821 Re: K041225 Trade/Device Name: Synthetic (Yellow) Vinyl Patient Examination Gloves --- Powdered Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: May 5, 2004 Received: May 10, 2004 Dear Mr. Chu: 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. {3}------------------------------------------------ Page 2 - Mr. Chu 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 vour device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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. Susan Runne Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K041225 Device Name: __ Synthetic (Yellow) Vinyl Patient Examination Gloves--Powdered Indications For Use: A 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. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ × (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)) K. Kelley (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: K041225 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K041225](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K041225) **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. 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