← Product Code [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY) · K150612 # Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free) (K150612) _Anhui Anyu Latex Products Co., Ltd. · LYY · Nov 16, 2015 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K150612 ## Device Facts - **Applicant:** Anhui Anyu Latex Products Co., Ltd. - **Product Code:** [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY.md) - **Decision Date:** Nov 16, 2015 - **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 examiner's hand or fingers to prevent contamination between patient and examiner. ## Device Story Disposable patient examination gloves; made of natural rubber latex or nitrile butadiene rubber latex; ambidextrous; cuffed; non-sterile; single-use. Act as physical barrier between examiner and patient to prevent contamination. Used in clinical settings by healthcare providers. Protects both examiner and patient from cross-contamination during examinations. ## Clinical Evidence Bench testing only. No clinical data included. Performance verified against ASTM D3578-10 (latex), ASTM D6319-10 (nitrile), ASTM D5151-11 (holes), ASTM D6124-11 (powder), ASTM D5712-10 (protein), and ISO 10993-10 (biocompatibility). ## Technological Characteristics Materials: Natural rubber latex or nitrile butadiene rubber latex. Polymer coating (polyurethane/polyacrylic acid) on powder-free versions. Non-sterile. Ambidextrous. Sizes: S, M, L. Standards: ASTM D3578-10, D6319-10, D5151-11, D6124-11, D5712-10, ISO 10993-10. ## 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 - Latex Examination Gloves (Powdered and Powder-Free) ([K072145](/device/K072145.md)) - Nitrile Examination Gloves (Powdered and Powder-Free) ([K072145](/device/K072145.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}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, suggesting a sense of community and support. The profiles are arranged in a way that creates a sense of depth and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 16, 2015 Anhui Anyu Latex Products Co., Ltd. c/o Doris Dong Shanghai CV Technology Co., Ltd. Room 1706. No. 128 Songle Rd., Songjiang Area Shanghai 201600 CHINA Re: K150612 Trade/Device Name: "Annuy Latex Patient Examination Glove (Powdered and Powder-free)" & "Annuy Nitrile Patient Examination Glove (Powdered and Powder-free)" Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: Class I Product Code: LYY, LYZ Dated: October 4, 2015 Received: October 16, 2015 Dear Ms. Dong: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {1}------------------------------------------------ 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, **Tejashri Purohit-Sheth, M.D.** Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K150612 #### Device Name Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free) Indications for Use (Describe) A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. Type of Use (Select one or both, as applicable) ] Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows a logo with a circular design. The top half of the circle is blue, while the bottom half is green. There are several curved lines in the green section that resemble blades of grass or leaves. The logo is set against a light blue background. # Section 5 510(k) Summary [As required by 21 CFR 807.92] #### 1. Submission Information: | 510(k) Number: | K150612 | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date: | Sept 30th, 2015 | | Type of 510(k) Submission: | Traditional | | Basis for 510(k) Submission: | New device | | Submitter/Manufacturer: | Anhui Anyu Latex Products Co., Ltd
East Qinji Road & North Xinghua Road, Bengbu, Anhui, 233010 China | | Contactor: | Doris Dong (Consultant)
Shanghai CV Technology Co., Ltd.
Room 1706, No. 128 Songle Rd., Songjiang Area, Shanghai, 201600 China
E-mail: doris_d@126.com
Tel: 86 21-31261348 / Fax: 86 21-37824346 | #### 2. Device Description: | Proprietary Name: | Annuy Latex Patient Examination Glove (powdered and powder-free);
Annuy Nitrile Patient Examination Glove (powdered and powder-free) | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Latex Examination Gloves (powdered and powder free);
Nitrile Examination Gloves (powdered and powder free) | | Classification Name: | Glove, patient examination, latex;
Glove, patient examination, poly | | Product Code: | LYY & LZA | | Device Class: | I | | Regulation Number: | 21 CFR 880.6250 | | Review Panel: | General Hospital | | Indications for use: | A patient examination glove is a disposable device intended for medical purposes that
is worn on the examiner's hand or fingers to prevent contamination between patient and
examiner | Device Description: Annuy Latex Patient Examination Glove (powdered and powder-free) is a glove made from natural rubber that covers the hand up to the wrist. It is cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. It has three sizes, i.e., large, medium, and small. All variations share the same natural color, creamy white. The glove is non-sterile and is for single use only, to be discarded after each examination is performed. It acts as a barrier between the examiner and the subject being examined in order to prevent contamination between them. Annuy Nitrile Patient Examination Glove (powdered and powder-free) is a glove made from nitrile butadiene rubber Latex that covers the hand up to the wrist. It is cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. It has three sizes, i.e. large, medium, and small. All variations share the same blue color. The glove is non-sterile and is for single use only, to be discarded after each examination is performed. It acts as a barrier between the examiner and the subject being examined in order to prevent contamination between them. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows a logo with a circular shape. The top half of the circle is blue, and the bottom half is green. There are several curved lines in the center of the circle, resembling a plant or a bird's wing. The logo is simple and clean, with a focus on natural elements. ### 3. Predicate Device Identification #### 510(k) Number: K072145 #### Product Name: Latex Examination Gloves (Powdered and Powder-Free) Nitrile Examination Gloves (Powdered and Powder-Free) Manufacturer: Zhanjiang Jiali Glove Products Co., LTD #### 4. Performance Test Data Summary #### • The Powdered Latex Patient Examination Gloves | Characteristics | Standard | | Test Data | | |-----------------------------|----------------------------------------------------------|-------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------| | Dimension | ASTM D3578-10 | | | | | Palm width | Size | (mm) | (mm) | | | | Small | 80±10 | 80~84 | | | | Medium | 95±10 | 93~97 | | | | Large | 111±10 | 107~109 | | | Overall Length | Size | (mm) | (mm) | | | | Small | 220 min | 240~246 | | | | Medium | 230 min | 241~248 | | | | Large | 230 min | 240~249 | | | Finger Thickness | Size | (mm) | (mm) | | | | Small | 0.08 min | 0.09~0.11 | | | | Medium | 0.08 min | 0.09~0.11 | | | | Large | 0.08 min | 0.09~0.12 | | | Palm Thickness | Size | (mm) | (mm) | | | | Small | 0.08 min | 0.10~0.12 | | | | Medium | 0.08 min | 0.10~0.12 | | | | Large | 0.08 min | 0.09~0.12 | | | Physical Properties | ASTM D3578-10 | | | | | | Before Aging | After aging at 70±2 °C
166±2 hrs | Before Aging | After aging at 70±2 °C
166±2 hrs | | - Tensile Strength | 18Mpa min | 14Mpa min | 20.3~35.1Mpa | 16.7~24.0Mpa | | - Ultimate Elongation | 650% min | 500% min | 961~1233% | 748~1021% | | - Stress at 500% Elongation | 5.5Mpa max | -- | 4.6~5.4Mpa | -- | | Freedom from Holes | ASTM D5151-11 | | Passed Standard Acceptance Criteria
Holes at Inspection Level I, AQL 2.5 | | | Powder Amount | ASTM D6124-11, ≤ 10mg/dm² | | 2.34 mg/dm², Meets ASTM D6124-11
Results generated values below 10mg/dm² of
residual powder | | | Protein Content | ASTM D5712-10, ≤200µg/dm² Aqueous
extractable protein | | Aqueous extractable protein: 72.1 mcg /dm²,
Meets ASTM D5712-10 Results generated | | values below 200µg/dm² of aqueous extractable {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows a logo with a circular design. The top half of the circle is light blue, while the bottom half is green. Within the green portion, there are several curved lines that resemble leaves or blades of grass. The overall design is simple and clean, with a focus on natural elements. | | | protein content | |------------------|-------------------------------------------------------------------|----------------------------------------------------| | Biocompatibility | Primary Skin Irritation in rabbits ISO
10993-10:2010-08-01 | Under the condition of the test, not an irritant. | | | | | | | Dermal sensitization in the guinea pig ISO
10993-10:2010-08-01 | Under the condition of the test, not a sensitizer. | | | | | #### • The Powder-free Latex Patient Examination Gloves | Characteristics | Standard | | Test Data | | |--------------------------------|----------------------------------------------------------|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------| | Dimension | ASTM D3578-10 | | | | | Palm width | Size | (mm) | | (mm) | | | Small | 80±10 | | 80~84 | | | Medium | 95±10 | | 93~97 | | | Large | 111±10 | | 107~109 | | Overall Length | Size | (mm) | | (mm) | | | Small | 220 min | | 240~246 | | | Medium | 230 min | | 241~248 | | | Large | 230 min | | 241~248 | | Finger Thickness | Size | (mm) | | (mm) | | | Small | 0.08 min | | 0.09~0.12 | | | Medium | 0.08 min | | 0.09~0.11 | | | Large | 0.08 min | | 0.09~0.12 | | Palm Thickness | Size | (mm) | | (mm) | | | Small | 0.08 min | | 0.10~0.12 | | | Medium | 0.08 min | | 0.10~0.12 | | | Large | 0.08 min | | 0.08~0.12 | | | | | | | | Physical Properties | ASTM D3578-10 | | | | | | Before Aging | After aging at 70±2 °C
166±2 hrs | Before Aging | After aging at 70±2 °C
166±2 hrs | | - Tensile Strength | 18Mpa min | 14Mpa min | 18.4~32.3Mpa | 18.7~24.5Mpa | | - Ultimate Elongation | 650% min | 500% min | 955~1148% | 797~976% | | - Stress at 500%
Elongation | 5.5Mpa max | -- | 4.8~5.4Mpa | -- | | | | | | | | | | | | | | Freedom from Holes | ASTM D5151-11 | | Passed Standard Acceptance Criteria
Holes at Inspection Level I, AQL 2.5 | | | Powder residue | ASTM D6124-11, ≤2mg/glove | | 0.68 mg/glove, Meets ASTM D6124-11
Results generated values below 2mg/glove of
residual powder | | | Protein Content | ASTM D5712-10, ≤200µg/dm2 Aqueous
extractable protein | | Aqueous extractable protein: 70.8 mcg/dm2,
Meets ASTM D5712-10, Results generated
values below 200µg/dm² of Aqueous extractable
protein content | | | Biocompatibility | Primary Skin Irritation in rabbits ISO | | Under the condition of the test, not an irritant. | | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows a logo with a circular design. The top half of the circle is blue, while the bottom half is green. Within the green portion, there are several curved lines that resemble blades of grass or leaves. The logo has a clean and modern look. | 10993-10:2010-08-01 | | |-------------------------------------------------------------------|----------------------------------------------------| | Dermal sensitization in the guinea pig ISO
10993-10:2010-08-01 | Under the condition of the test, not a sensitizer. | ### • The Powdered Nitrile Patient Examination Gloves | • The Powdered Nitrile Patient Examination Gloves | | | | | |---------------------------------------------------|-------------------------------------------------------------------|-------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------| | Characteristics | Standard | | | Test Data | | Dimension | ASTM D6319-10 | | | | | Palm width | Size | (mm) | | (mm) | | | Small | 80±10 | | 81~85 | | | Medium | 95±10 | | 95~99 | | | Large | 110±10 | | 110~114 | | Overall Length | Size | (mm) | | (mm) | | | Small | 220 min | | 251~255 | | | Medium | 230 min | | 250~262 | | | Large | 230 min | | 259~264 | | Finger Thickness | Size | (mm) | | (mm) | | | Small | 0.05 min | | 0.08 | | | Medium | 0.05 min | | 0.08 | | | Large | 0.05 min | | 0.08 | | Palm Thickness | Size | (mm) | | (mm) | | | Small | 0.05 min | | 0.08 | | | Medium | 0.05 min | | 0.08 | | | Large | 0.05 min | | 0.08 | | | | | | | | Physical Properties | ASTM D6319-10 | | | | | | Before Aging | After aging at 70±2 °C
166±2 hrs | Before Aging | After aging at 70±2 °C
166±2 hrs | | - Tensile Strength | 14Mpa min | 14Mpa min | 17.5~31.1Mpa | 15.7~18.5Mpa | | - Ultimate Elongation | 500% min | 400% min | 761~948% | 421~839% | | | | | | | | Freedom from Holes | ASTM D5151-11 | | Passed Standard Acceptance Criteria | | | | | | Holes at Inspection Level G-1, AQL 2.5 | | | Powder Amount | ASTM D6124-11, ≤ 10mg/dm² | | 1.86 mg/dm², Meets ASTM D6124-11
Results generated values below 10mg/dm² of
residual powder | | | | | | | | | | | | | | | Biocompatibility | Primary Skin Irritation in rabbits ISO
10993-10:2010-08-01 | | Under the condition of the test, not an irritant. | | | | Dermal sensitization in the guinea pig ISO
10993-10:2010-08-01 | | Under the condition of the test, not a sensitizer. | | | | | | | | ### • The Powder-free Nitrile Patient Examination Gloves | Characteristics | Standard | Test Data | |-----------------|---------------|-----------| | Dimension | ASTM D6319-10 | | | Palm width | Size (mm) | (mm) | {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows a logo with a circular shape. The top half of the circle is blue, and the bottom half is green. Inside the circle, there are several curved lines that resemble leaves or blades of grass. The lines are also green and are arranged in a fan-like pattern. | | Small | 80±10 | | 81~85 | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------| | | Medium | 95±10 | | 94~99 | | | Large | 110±10 | | 110~114 | | Overall Length | Size | (mm) | | (mm) | | | Small | 220 min | | 252~257 | | | Medium | 230 min | | 255~260 | | | Large | 230 min | | 257~263 | | Finger Thickness | Size | (mm) | | (mm) | | | Small | 0.05 min | | 0.08 | | | Medium | 0.05 min | | 0.08 | | | Large | 0.05 min | | 0.08 | | Palm Thickness | Size | (mm) | | (mm) | | | Small | 0.05 min | | 0.08 | | | Medium | 0.05 min | | 0.08 | | | Large | 0.05 min | | 0.08 | | | | | | | | Physical Properties | ASTM D6319-10 | | | | | | Before Aging | After aging at 70±2 °C
166±2 hrs | Before Aging | After aging at 70±2 °C
166±2 hrs | | - Tensile Strength | 14Mpa min | 14Mpa min | 18.8~29.5Mpa | 16.2~21.0Mpa | | - Ultimate Elongation | 500% min | 400% min | 745~945% | 445~773% | | | | | | | | Freedom from Holes | ASTM D5151-11 | | Passed Standard Acceptance Criteria
Holes at Inspection Level G-1, AQL 2.5 | | | Powder residue | ASTM D6124-11, ≤2mg/glove | | 0.72 mg/glove, Meets ASTM D6124-11
Results generated values below 2mg/glove of
residual powder | | | Biocompatibility | Primary Skin Irritation in rabbits ISO
10993-10:2010-08-01
Dermal sensitization in the guinea pig ISO
10993-10:2010-08-01 | | Under the condition of the test, not an irritant.

Under the condition of the test, not a sensitizer. | | ## 5. Substantial Equivalent Based on Assessment of Non-Clinical Performance Data: Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: 1) ASTM D3578-10, Standard Specification for Rubber Examination Gloves. 2) ASTM D5151-11, Standard Test Method for Detection of Holes in Medical Gloves. 3) ASTM D6124-11, Standard Test Method for Residual Powder on Medical Gloves. 4) ASTM D5712-10, Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rs Products Using the Modified Lowry Method. 5) ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. 6) ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization. ## 6. Substantial Equivalent Based on Assessment of Clinical Performance Data: {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows a logo with a circular design. The logo features a blue circle with a green, stylized image of a plant or bird inside. The green image has several curved lines that resemble leaves or feathers. The overall design is simple and modern. Clinical data was not including in this submission. ## 7. Substantially Equivalent Comparison Conclusion ## • For Powdered Latex Patient Examination Gloves | Parameters | | New Device | Predicate Device | |------------|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | 510(k) Number | K150612 | K072145 | | 2 | Marketing
clearance date | -- | Feb 26th, 2008 | | 3 | Device Name | Annuy Powdered Latex Patient Examination
Glove | Powdered Latex Patient Examination Glove | | 4 | Manufacturer | Anhui Anyu Latex Products Co., Ltd | Zhanjiang Jiali Glove Products Co., LTD | | 5 | Product Code | LYY | LYY | | 6 | Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | | 7 | Class | I | I | | 8 | Intended 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. | 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. | | 9 | Material | Natural Rubber Latex | Natural Rubber Latex | | 10 | Design | Single use
Non-sterile
Powdered
Ambidextrous
Cuffed | Single use
Non-sterile
Powdered
Ambidextrous
Cuffed | | 11 | Description | A device covering the hand and wrist area.
Gloves have separate sheaths or openings for
each finger and the thumb. | A device covering the hand and wrist area.
Gloves have separate sheaths or openings
for each finger and the thumb. | | 12 | Size | Provided in sizes small, medium and large | Provided in sizes small, medium and large | | 13 | Specifications | Powdered Latex Examination Gloves Meet
ASTM D3578-10 | Powdered Latex Examination Gloves Meet
ASTM D3578-05 | | 14 | Dimensions
- Overall Length | Meets ASTM D3578-10
Small: 220mm min
Medium: 230mm min
Large: 230mm min | Meets ASTM D3578-05
Small: 220mm min
Medium: 230mm min
Large: 230mm min | | 15 | Dimensions
- Palm Width | Meets ASTM D3578-10
Small: 80±10mm
Medium: 95±10mm
Large: 111±10mm | Meets ASTM D3578-05
Small: 80±10mm
Medium: 95±10mm
Large: 111±10mm | | 16 | Dimensions
- Finger Thickness | Meets ASTM D3578-10
0.08mm min | Meets ASTM D3578-05
0.08mm min | | | Dimensions
- Palm Thickness | Meets ASTM D3578-10
0.08mm min | Meets ASTM D3578-05
0.08mm min | | 17 | Physical Properties | Meets ASTM D3578-10 | Meets ASTM D3578-05 | | | | Before Aging: | Before Aging: | | | | - Tensile Strength: 18Mpa min | - Tensile Strength: 18Mpa min | | | | - Ultimate Elongation: 650% min | - Ultimate Elongation: 650% min | | | | - Stress at 500% Elongation: 5.5Mpa max | - Stress at 500% Elongation: 5.5Mpa max | | | | Meets ASTM D3578-10 | Meets ASTM D3578-05 | | | | After aging at 70±2 °C 166±2 hrs: | After aging at 70±2 °C 166±2 hrs: | | | | - Tensile Strength: 14Mpa min | - Tensile Strength: 14Mpa min | | | | - Ultimate Elongation: 500% min | - Ultimate Elongation: 500% min | | 18 | Freedom from | Meets ASTM D3578-10 and ASTM D5151-11 | Meets ASTM D3578-05 and ASTM | | | Holes | Holes at Inspection Level I, AQL 2.5 | D5151-06 | | 19 | Powder Amount | Meets ASTM D6124-11 | Meets ASTM D6124-06 | | | | Below 10mg/dm² of residual powder | Below 10mg/dm² of residual powder | | 20 | Protein Content | Meets ASTM D5712-10, | Meets ASTM D5712-05 | | | | Below 200µg/dm² of aqueous extractable | Below 200µg/dm² of aqueous extractable | | | | protein content | protein content | | 21 | Absorbable donning | Cornstarch, | Cornstarch, | | | or dusting powder | Powdered with absorbable dusting powder, | Powdered with absorbable dusting powder, | | | | U.S.P. | U.S.P. | | 22 | Biocompatibility | Meets ISO 10993-10:2010; | Meets ISO 10993-10:2006; | | | | Skin Irritation: Under the condition of the | Skin Irritation: Under the condition of the | | | | test, not an irritant. | test, not an irritant. | | | | Skin Sensitization:Under the condition of the | Skin Sensitization:Under the condition of | | | | test, not a sensitizer. | the test, not a sensitizer. | | 23 | Color | Creamy white, no colorant | Same | | 24 | Labeling Features | Include the required labeling: | Include the required labeling: | | | | • Examination Gloves | • Examination Gloves | | | | • Non-sterile | • Single Use Only | | | | • Single Use Only | • Powdered | | | | • Powdered | • Size, Serial No., Manufacturing Date and | | | | • Ambidextrous | Quantity | | | | • Natural rubber latex | • Natural rubber latex | | | | • Device color: Creamy white | • Protein Label Claims | | | | • Allergy warning | • Allergy warning | | | | • Contents, Size, Lot No. and Manufacturing | • Manufacturer Name and Address | | | | Date | | | | | • Storage conditions | | | | | • Manufacturer Name and Address | | {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows a logo with a circular design. The top half of the circle is blue, while the bottom half is green. Within the green portion, there are several curved lines that resemble blades of grass or stylized leaves. The overall design is simple and modern, suggesting a connection to nature or the environment. # • For Powder-free Latex Patient Examination Gloves | | Parameters | New Device | Predicate Device | |-------------------------------------------------------------------------------------------------------|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | 510(k) Number | K150612… --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K150612](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K150612) **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