(251 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and biocompatibility of examination gloves, with no mention of AI or ML technologies.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner, acting as a barrier rather than providing therapy.
No
The device, a patient examination glove, acts as a barrier to prevent contamination, not to diagnose a condition.
No
The device description clearly states it is a physical glove made from natural rubber or nitrile butadiene rubber, intended to be worn on the hand. It describes physical characteristics like material, size, color, and cuff. The performance studies focus on physical properties and biocompatibility, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner." This describes a barrier device for protection, not a device used to perform tests on samples taken from the human body to provide diagnostic information.
- Device Description: The description focuses on the physical properties and materials of the gloves (latex, nitrile, size, color, single-use, non-sterile). It does not mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies described are bench tests evaluating the physical properties, freedom from holes, powder content, protein content, and biocompatibility of the gloves. These are relevant to the safety and effectiveness of a barrier device, not the accuracy of a diagnostic test.
- Key Metrics: The key metrics mentioned are related to the physical characteristics and biocompatibility of the gloves, not diagnostic performance metrics like sensitivity, specificity, PPV, or NPV.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostic devices.
In summary, the device is a medical glove intended for barrier protection during patient examinations. This falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LYY, LYZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- ASTM D3578-10, Standard Specification for Rubber Examination Gloves.
- ASTM D5151-11, Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-11, Standard Test Method for Residual Powder on Medical Gloves.
- ASTM D5712-10, Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rs Products Using the Modified Lowry Method.
- ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
- ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
Key results:
- The Powdered Latex Patient Examination Gloves: Palm width (Small: 80
84mm, Medium: 9397mm, Large: 107109mm), Overall Length (Small: 240246mm, Medium: 241248mm, Large: 240249mm), Finger Thickness (Small: 0.090.11mm, Medium: 0.090.11mm, Large: 0.090.12mm), Palm Thickness (Small: 0.100.12mm, Medium: 0.100.12mm, Large: 0.090.12mm). Before Aging: Tensile Strength 20.335.1Mpa, Ultimate Elongation 9611233%. After aging at 70±2 °C 166±2 hrs: Tensile Strength 16.724.0Mpa, Ultimate Elongation 7481021%. Passed Freedom from Holes (Inspection Level I, AQL 2.5). Powder Amount: 2.34 mg/dm². Protein Content: 72.1 mcg/dm². Biocompatibility: not an irritant, not a sensitizer. - The Powder-free Latex Patient Examination Gloves: Palm width (Small: 80
84mm, Medium: 9397mm, Large: 107109mm), Overall Length (Small: 240246mm, Medium: 241248mm, Large: 241248mm), Finger Thickness (Small: 0.090.12mm, Medium: 0.090.11mm, Large: 0.090.12mm), Palm Thickness (Small: 0.100.12mm, Medium: 0.100.12mm, Large: 0.080.12mm). Before Aging: Tensile Strength 18.432.3Mpa, Ultimate Elongation 9551148%. After aging at 70±2 °C 166±2 hrs: Tensile Strength 18.724.5Mpa, Ultimate Elongation 797976%. Passed Freedom from Holes (Inspection Level I, AQL 2.5). Powder residue: 0.68 mg/glove. Protein Content: 70.8 mcg/dm². Biocompatibility: not an irritant, not a sensitizer. - The Powdered Nitrile Patient Examination Gloves: Palm width (Small: 81
85mm, Medium: 9599mm, Large: 110114mm), Overall Length (Small: 251255mm, Medium: 250262mm, Large: 259264mm), Finger Thickness (Small: 0.08mm, Medium: 0.08mm, Large: 0.08mm), Palm Thickness (Small: 0.08mm, Medium: 0.08mm, Large: 0.08mm). Before Aging: Tensile Strength 17.531.1Mpa, Ultimate Elongation 761948%. After aging at 70±2 °C 166±2 hrs: Tensile Strength 15.718.5Mpa, Ultimate Elongation 421839%. Passed Freedom from Holes (Inspection Level G-1, AQL 2.5). Powder Amount: 1.86 mg/dm². Biocompatibility: not an irritant, not a sensitizer. - The Powder-free Nitrile Patient Examination Gloves: Palm width (Small: 81
85mm, Medium: 9499mm, Large: 110114mm), Overall Length (Small: 252257mm, Medium: 255260mm, Large: 257263mm), Finger Thickness (Small: 0.08mm, Medium: 0.08mm, Large: 0.08mm), Palm Thickness (Small: 0.08mm, Medium: 0.08mm, Large: 0.08mm). Before Aging: Tensile Strength 18.829.5Mpa, Ultimate Elongation 745945%. After aging at 70±2 °C 166±2 hrs: Tensile Strength 16.221.0Mpa, Ultimate Elongation 445773%. Passed Freedom from Holes (Inspection Level G-1, AQL 2.5). Powder residue: 0.72 mg/glove. Biocompatibility: not an irritant, not a sensitizer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
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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)
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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.
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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
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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. |
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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) |
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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:
-
ASTM D3578-10, Standard Specification for Rubber Examination Gloves.
-
ASTM D5151-11, Standard Test Method for Detection of Holes in Medical Gloves.
-
ASTM D6124-11, Standard Test Method for Residual Powder on Medical Gloves.
-
ASTM D5712-10, Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rs
Products Using the Modified Lowry Method.
-
ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
-
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 | K072145 |
| 2 | Marketing | ||
| clearance date | -- | Feb 26th, 2008 | |
| 3 | Device Name | Annuy Powder free Latex Patient Examination Glove | Powder free 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 | |||
| Powder free | |||
| Ambidextrous | |||
| Cuffed | Single use | ||
| Non-sterile | |||
| Powder free | |||
| 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
Before Aging: - Tensile Strength: 18Mpa min
- Ultimate Elongation: 650% min
- Stress at 500% Elongation: 5.5Mpa max
Meets ASTM D3578-10
After aging at 70±2 °C 166±2 hrs: - Tensile Strength: 14Mpa min
- Ultimate Elongation: 500% min | Meets ASTM D3578-05
Before Aging: - Tensile Strength: 18Mpa min
- Ultimate Elongation: 650% min
- Stress at 500% Elongation: 5.5Mpa max
Meets ASTM D3578-05
After aging at 70±2 °C 166±2 hrs: - Tensile Strength: 14Mpa min
- Ultimate Elongation: 500% min |
| 18 | Freedom from
Holes | Meets ASTM D3578-10 and ASTM D5151-11
Holes at Inspection Level I, AQL 2.5 | Meets ASTM D3578-05 and ASTM
D5151-06 |
| ANHUI YU LATEX PRODUCTS CO., LTD
EAST QINJI ROAD & NORTH XINGHUA ROAD, BENGBU, ANHUI, 233010 CHINA | | | |
| 19 | Powder residue | Meets ASTM D6124-11
Below 2mg/glove of residual powder | Meets ASTM D6124-06
Below 2mg/glove of residual powder |
| 20 | Protein Content | Meets ASTM D5712-10,
Below 200µg/dm² of aqueous soluble protein
content | Meets ASTM D5712-05,
Below 200µg/dm² of aqueous soluble
protein content |
| 21 | Polymer Coating | It is coated with a polyurethane based coating
on the inner side to facilitate donning.
Polymer name: polyurethane & polyacrylic
acid | It is coated with a polyurethane based
coating on the inner side to facilitate
donning.
Polymer name: polyurethane & polyacrylic
acid |
| 22 | Biocompatibility | Meets ISO 10993-10:2010;
Skin Irritation: Under the condition of the
test, not an irritant.
Skin Sensitization: Under the condition of the
test, not a sensitizer. | Meets ISO 10993-10:2006;
Skin Irritation: Under the condition of the
test, not an irritant.
Skin Sensitization: Under the condition of
the test, not a sensitizer. |
| 23 | Color | Creamy white, no colorant | Creamy white, no colorant |
| 24 | Labeling Features | Include the required labeling:
• Examination Gloves
• Non-sterile
• Disposable
• Powder-free
• Ambidextrous
• Natural rubber latex
• Device color: Creamy white
• Allergy warning
• Contents, Size, Lot No. and Manufacturing
Date
• Storage conditions | Include the required labeling:
• Examination Gloves
• Single Use Only
• Powder-free
• Size, Serial No., Manufacturing Date and
Quantity
• Natural rubber latex
• Protein Label Claims
• Allergy warning
• Manufacturer Name and Address |
10
11
ANHUI ANYU LATEX PRODUCTS CO., LTD EA
• For Powdered Nitrile Patient Examination Gloves
• Manufacturer Name and Address
| Parameters | New Device | Predicate Device | |
|---|---|---|---|
| 1 | 510(k) Number | K150612 | K072145 |
| 2 | Marketing clearance date | -- | Feb 26th, 2008 |
| 3 | Device Name | Annuy Powdered Nitrile Patient Examination Glove | Powdered Nitrile Patient Examination Glove |
| 4 | Manufacturer | Anhui Anyu Latex Products Co., Ltd | Zhanjiang Jiali Glove Products Co., LTD |
| 5 | Product Code | LZA | LZA |
| 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 | 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. | examiner. | ||
| 9 | Material | Nitrile Butadiene Rubber Latex | Nitrile Butadiene Rubber Latex |
| 10 | Design | Single use | Single use |
| Non-sterile | Non-sterile | ||
| Powdered | Powdered | ||
| Ambidextrous | Ambidextrous | ||
| Cuffed | Cuffed | ||
| 11 | Description | A device covering the hand and wrist area. | A device covering the hand and wrist area. |
| Gloves have separate sheaths or openings for | Gloves have separate sheaths or openings | ||
| each finger and the thumb. | 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 Nitrile Examination Gloves Meet | Powdered Nitrile Examination Gloves Meet |
| ASTM D6319-10 | ASTM D6319-05 | ||
| 14 | Dimensions | Meets ASTM D6319-10 | Meets ASTM D6319-05 |
| - Overall Length | Small: 220mm min | Small: 220mm min | |
| Medium: 230mm min | Medium: 230mm min | ||
| Large: 230mm min | Large: 230mm min | ||
| 15 | Dimensions | Small: 80±10mm | Small: 80±10mm |
| - Palm Width | Medium: 95±10mm | Medium: 95±10mm | |
| Large: 110±10mm | Large: 110±10mm | ||
| Meets ASTM D6319-10 | Meets ASTM D6319-05 | ||
| 16 | Dimensions | Meets ASTM D6319-10 | Meets ASTM D6319-05 |
| - Finger Thickness | 0.05mm min | 0.05mm min | |
| Dimensions | Meets ASTM D6319-10 | Meets ASTM D6319-05 | |
| - Palm Thickness | 0.05mm min | 0.05mm min | |
| 17 | Physical Properties | Meets ASTM D6319-10 | Meets ASTM D6319-05 |
| Before Aging: | Before Aging: | ||
| - Tensile Strength: 14Mpa min | - Tensile Strength: 14Mpa min | ||
| - Ultimate Elongation:500% min | - Ultimate Elongation:500% min | ||
| Meets ASTM D6319-10 | Meets ASTM D6319-05 | ||
| 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: 400% min | - Ultimate Elongation: 400% min | ||
| 18 | Freedom from | Meets ASTM D6319-10 and ASTM | Meets ASTM D6319-05 and ASTM |
| Holes | D5151-11; | D5151-06 | |
| Holes at Inspection Level G-1, AQL 2.5 | |||
| 19 | Powder Amount | Meets ASTM D6124-11, | Meets ASTM D6124-06 |
| Below 10mg/dm² | Below 10mg/dm² of residual powder | ||
| 20 | Absorbable donning | Cornstarch, | Cornstarch, |
| or dusting powder | Powdered with absorbable dusting powder, | Powdered with absorbable dusting powder, | |
| U.S.P. | U.S.P. | ||
| 21 | 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. | ||
| 22 | Color | Blue | |
| Chemical characterization: | |||
| Copper Phthalocyanine β modification | Blue | ||
| Chemical characterization: | |||
| Copper Phthalocyanine β modification | |||
| 23 | Labeling Features | Include the required labeling: | |
| • Nitrile Examination Gloves | |||
| • Non-sterile | |||
| • Disposable | |||
| • Powdered | |||
| • Ambidextrous | |||
| • Device color: Blue | |||
| • Contents, Size, Lot No. and Manufacturing Date | |||
| • Storage conditions | |||
| • Manufacturer Name and Address | Include the required labeling: | ||
| • Nitrile Examination Gloves | |||
| • Single Use Only | |||
| • Powdered | |||
| • Size, Serial No., Manufacturing Date and Quantity | |||
| • Manufacturer Name and Address |
12
13
Image /page/13/Picture/1 description: The image shows a logo with a circular shape. The left side of the circle is blue, while the right side is green. Inside the circle, there are curved lines that resemble a plant or a wave. The logo has a clean and modern design.
• For Powder-free Nitrile 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 Powder-free Nitrile Patient Examination Glove | Powder-free Nitrile Patient Examination Glove |
| 4 | Manufacturer | Anhui Anyu Latex Products Co., Ltd | Zhanjiang Jiali Glove Products Co., LTD |
| 5 | Product Code | LZA | LZA |
| 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 | Nitrile Butadiene Rubber Latex | Nitrile Butadiene Rubber Latex |
| 10 | Design | Single use | |
| Non-sterile | |||
| Powder-free | |||
| Ambidextrous | |||
| Cuffed | Single use | ||
| Non-sterile | |||
| Powder-free | |||
| 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 | Powder-free Nitrile Examination Gloves Meet ASTM D6319-10 | Powder-free Nitrile Examination Gloves Meet ASTM D6319-05 |
| 14 | Dimensions |
- Overall Length | Meets ASTM D6319-10
Small: 220mm min
Medium: 230mm min
Large: 230mm min | Meets ASTM D6319-05
Small: 220mm min
Medium: 230mm min
Large: 230mm min |
| 15 | Dimensions - Palm Width | Meets ASTM D6319-10
Small: 80±10mm
Medium: 95±10mm
Large: 110±10mm | Meets ASTM D6319-05
Small: 80±10mm
Medium: 95±10mm
Large: 110±10mm |
| 16 | Dimensions - Finger Thickness | Meets ASTM D6319-10
0.05mm min | Meets ASTM D6319-05
0.05mm min |
| | Dimensions - Palm Thickness | Meets ASTM D6319-10
0.05mm min | Meets ASTM D6319-05
0.05mm min |
| 17 | Physical Properties | Meets ASTM D6319-10
Before Aging: - Tensile Strength: 14Mpa min
- Ultimate Elongation:500% min
Meets ASTM D6319-10
After aging at 70±2 °C 166±2 hrs: - Tensile Strength: 14Mpa min
- Ultimate Elongation: 400% min | Meets ASTM D6319-05
Before Aging: - Tensile Strength: 14Mpa min
- Ultimate Elongation:500% min
Meets ASTM D6319-05
After aging at 70±2 °C 166±2 hrs: - Tensile Strength: 14Mpa min
- Ultimate Elongation: 400% min |
| 18 | Freedom from
Holes | Meets ASTM D6319-10 and ASTM
D5151-11;
Holes at Inspection Level G-1, AQL 2.5 | Meets ASTM D6319-05 and ASTM
D5151-06 |
| 19 | Powder residue | Meets ASTM D6124-11
Below 2mg/glove of residual powder | Meets ASTM D6124-06
Below 2mg/glove of residual powder |
| 20 | Polymer Coating | It is coated with a polyurethane based coating
on the inner side to facilitate donning.
Polymer name: polyurethane & polyacrylic
acid | It is coated with a polyurethane based
coating on the inner side to facilitate
donning.
Polymer name: polyurethane & polyacrylic
acid |
| 21 | Biocompatibility | Meets ISO 10993-10:2010;
Skin Irritation: Under the condition of the
test, not an irritant.
Skin Sensitization:Under the condition of the
test, not a sensitizer. | Meets ISO 10993-10:2006;
Skin Irritation: Under the condition of the
test, not an irritant.
Skin Sensitization: Under the condition of
the test, not a sensitizer. |
| 22 | Color | Blue
Chemical characterization:
Copper Phthalocyanine β modification | Blue
Chemical characterization:
Copper Phthalocyanine β modification |
| 23 | Labeling Features | Include the required labeling:
• Nitrile Examination Gloves
• Non-sterile
• Disposable
• Powder-free
• Ambidextrous | Include the required labeling:
• Nitrile Examination Gloves
• Single Use Only
• Powder-free
• Size, Serial No., Manufacturing Date and
Quantity |
14
Image /page/14/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 overall design is simple and clean, with a focus on natural elements.
15
Image /page/15/Picture/1 description: The image shows a logo with a circular shape. The top half of the circle is blue, while the bottom half is green. Within the green portion, there are several white lines that resemble blades of grass or stylized leaves. The overall design is simple and clean, suggesting a focus on nature or the environment.
| | Contents, Size, Lot No. and Manufacturing
Date Storage conditions Manufacturer Name and Address |
| -- | ---------------------------------------------------------------------------------------------------- |
|---|
Discussion: Based on the above comparison, the Annuy Latex Examination Gloves (Powdered and Powder-Free), Annuy Nitrile Examination Gloves (Powdered and Powder-Free) and the predicate device have same technology characteristics such as material, design, intended use, specification and performance features.
Both the subject device and predicate device meet the technology characteristics of ASTM D3578, ASTM D6319 and ISO10993-10 standards. From the tests, results generated values that,
Annuy Powdered Latex Examination Gloves contain no more than 10mg/dm² powder and no more than 200µg/dm² extractable protein.
Annuy Powder-free Latex Examination Gloves contain no more than 2mg/glove of residual powder and no more than 200ug/dm2 extractable protein.
Annuy Powdered Nitrile Examination Gloves contain no more than 10mg/dm² powder.
Annuy Powder-free Nitrile Examination Gloves contain no more than 2mg/glove of residual powder.
Conclusion: The Annuy Latex Examination Gloves (Powder-Free) and Nitrile Examination Gloves
(Powdered and Powder-Free) manufactured by Anhui Anyu Latex Products Co., Ltd are substantially equivalent to the predicate device (K072145).