(251 days)
A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device, Latex Surgeon's Gloves (Powdered and Powder Free) is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, per standard ASTM D3577-0961, the rubber surgical gloves classification is: "Type I - gloves compounded primarily from natural rubber latex". The proposed device includes Powdered and Powder Free Latex Surgeon's Gloves, and variations of different size. All variations share the same color, creamy white. The proposed device is provided radiation sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and place in a sterility maintenance package to ensure a shelf life of 3 years.
This document describes the performance testing for "Annuy Latex Surgeon's Gloves (Powdered and Powder Free)" to demonstrate substantial equivalence to a predicate device (K130301). The study is a non-clinical bench test study.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is compared against various ASTM and ISO standards. The tables below summarize the acceptance criteria (standards) and the reported device performance for both powdered and powder-free gloves.
For Powdered Latex Surgeon's Gloves:
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension (ASTM 3577-09e1) | ||
| Palm width | Size 6: 76±6 mm, 6 1/2: 83±6 mm, 7: 89±6 mm, 7 1/2: 95±6 mm, 8: 102±6 mm, 8 1/2: 108±6 mm, 9: 114±6 mm | Size 6: 76 |
| Overall Length | 265 mm min | Size 6: 267 |
| Finger Thickness | 0.10 mm min | 0.10~0.13 mm range across sizes (All reported values meet or exceed the minimum) |
| Palm Thickness | 0.10 mm min | 0.10~0.13 mm range across sizes (All reported values meet or exceed the minimum) |
| Cuff thickness | 0.10 mm min | 0.10~0.13 mm range across sizes (All reported values meet or exceed the minimum) |
| Physical Properties (ASTM 3577-09e1) | ||
| - Tensile Strength (Before Aging) | 24 MPa, min | Reported values for Powdered Gloves are not explicitly listed in the "Test Data" column, but the "Substantially Equivalent Comparison Conclusion" table confirms "Meets ASTM D3577-09e1" and lists the same acceptance criteria as the predicate. The overall conclusion states tests "demonstrated that the proposed device complies with the following standards". |
| - Ultimate Elongation (Before Aging) | 750% min | Same as above. |
| - Stress at 500% Elongation | 5.5 MPa, max | Same as above. |
| - Tensile Strength (After Aging) | 18 MPa, min (at 70±2 °C, 166±2 hrs) | Same as above. |
| - Ultimate Elongation (After Aging) | 560% min (at 70±2 °C, 166±2 hrs) | Same as above. |
| Freedom from Holes (ASTM D5151-11) | Standard Acceptance Criteria: Holes at Inspection Level I, AQL 1.5 | Passed Standard Acceptance Criteria: Holes at Inspection Level I, AQL 1.5 |
| Powder Amount (ASTM D6124-11) | ≤ 15 mg/dm² | 1.43 mg/dm², Meets ASTM D6124-06 (Reapproved 2011), Results generated values below 15 mg/dm² of Powder amount. |
| Protein Content (ASTM D5712-10) | ≤ 200 µg/dm² Aqueous extractable protein | Aqueous extractable protein: 132 mcg/dm², Meets ASTM D5712-10, Results generated values below 200 µg/dm² of aqueous extractable protein content. |
| Biocompatibility (ISO 10993-10:2010-08-01) | ||
| - Primary Skin Irritation | Not an irritant | Under the condition of the test, not an irritant. |
| - Dermal Sensitization | Not a sensitizer | Under the condition of the test, not a sensitizer. |
| Sterilization Validation (ISO 11137-1:2006) | Sterility Assurance Level (SAL) of 10-6 | Sterility Assurance Level (SAL) of 10-6 |
For Powder-free Latex Surgeon's Gloves:
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension (ASTM 3577-09e1) | ||
| Palm width | Size 6: 76±6 mm, 6 1/2: 83±6 mm, 7: 89±6 mm, 7 1/2: 95±6 mm, 8: 102±6 mm, 8 1/2: 108±6 mm, 9: 114±6 mm | Size 6: 76 |
| Overall Length | 265 mm min | Size 6: 268 |
| Finger Thickness | 0.10 mm min | 0.10~0.13 mm range across sizes (All reported values meet or exceed the minimum) |
| Palm Thickness | 0.10 mm min | 0.10~0.13 mm range across sizes (All reported values meet or exceed the minimum) |
| Cuff thickness | 0.10 mm min | 0.10~0.13 mm range across sizes (All reported values meet or exceed the minimum) |
| Physical Properties (ASTM 3577-09e1) | ||
| - Tensile Strength (Before Aging) | 24 MPa, min | 24.1-40.8 MPa (Reported values exceed the minimum) |
| - Ultimate Elongation (Before Aging) | 750% min | 961%-1239% (Reported values exceed the minimum) |
| - Stress at 500% Elongation | 5.5 MPa, max | 4.3~4.7 MPa (Reported values are below the maximum) |
| - Tensile Strength (After Aging) | 18 MPa, min (at 70±2 °C, 166±2 hrs) | 20.8-27.4 MPa (Reported values exceed the minimum) |
| - Ultimate Elongation (After Aging) | 560% min (at 70±2 °C, 166±2 hrs) | 761%-1103% (Reported values exceed the minimum) |
| Freedom from Holes (ASTM D5151-11) | Standard Acceptance Criteria: Holes at Inspection Level I, AQL 1.5 | Passed Standard Acceptance Criteria: Holes at Inspection Level I, AQL 1.5 |
| Powder residue (ASTM D6124-11) | ≤ 2 mg/glove | 0.6 mg/glove, Meets ASTM D6124-06 (Reapproved 2011), Results generated values below 2 mg of residual powder. |
| Protein Content (ASTM D5712-10) | ≤ 200 µg/dm² Aqueous extractable protein | Aqueous extractable protein: 61.6 mcg/dm², Meets ASTM D5712-10, Results generated values below 200 µg/dm² of Aqueous extractable protein content. |
| Biocompatibility (ISO 10993-10:2010-08-01) | ||
| - Primary Skin Irritation | Not an irritant | Under the condition of the test, not an irritant. |
| - Dermal Sensitization | Not a sensitizer | Under the condition of the test, not a sensitizer. |
| Sterilization Validation (ISO 11137-1:2006) | Sterility Assurance Level (SAL) of 10-6 | Sterility Assurance Level (SAL) of 10-6 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the exact sample size for each test. For example, for "Palm width," it provides a range of measured values (e.g., 76~80 mm for size 6) rather than listing individual measurements or a specific count of gloves tested. However, the tests are stated to comply with referenced ASTM and ISO standards, which typically specify minimum sample sizes for such evaluations.
- Data Provenance: The testing was conducted by Anhui Anyu Latex Products Co., Ltd in China. It is a retrospective study since the data is collected and presented after the manufacturing and testing of the gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes non-clinical, bench testing of physical and chemical properties of a medical device (surgical gloves). As such, "ground truth" is established by adherence to recognized international standards (ASTM and ISO). There are no human experts used to establish a clinical ground truth for this type of test.
4. Adjudication Method for the Test Set
Not applicable. The product performance is evaluated against objective, standardized criteria defined by ASTM and ISO specifications, not subjective human assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This is a non-clinical bench test report for physical and chemical properties of gloves, not a clinical study involving human readers or cases.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to a medical device, specifically surgical gloves, and not an algorithm or AI. Therefore, this question is not applicable. The performance described here is the inherent physical and chemical properties of the manufactured glove itself, which are measured using various testing methodologies.
7. The Type of Ground Truth Used
The "ground truth" for the test results is established by objective, quantitative measurements against the pre-defined specifications and acceptance criteria outlined in the referenced ASTM and ISO standards (e.g., ASTM D3577-09e1 for dimensions and physical properties, ASTM D5151-11 for freedom from holes, ASTM D6124-11 for powder amount, ASTM D5712-10 for protein content, ISO 10993-10 for biocompatibility, and ISO 11137-1:2006 for sterilization).
8. The Sample Size for the Training Set
Not applicable. This is a report on the testing of a manufactured medical device, not an AI/ML algorithm development. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set was Established
Not applicable. As explained above, this is not an AI/ML algorithm study.
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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: K150609
Trade/Device Name: Annuy Latex Surgeon's Gloves (Powdered and Powder Free) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's glove Regulatory Class: Class I Product Code: KGO Dated: October 6, 2015 Received: October 14, 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.
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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Annuy Latex Surgeon's Gloves (Powdered and Powder Free)
Indications for Use (Describe)
A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
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) Summarv
[As required by 21 CFR 807.92]
1. Submission Information: 510(k) Number: K150609 Sept 30th, 2015 Date: 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
2. Device Description: Proprietary Name: Annuy Latex Surgeon's Gloves (Powdered and Powder Free) Common Name: Surgical Gloves Classification Name: surgeon's gloves Product Code: Surgeon's Glove - 79KGO Device Class: T Regulation Number: 21 CFR 878,4460 Review Panel: General & Plastic Surgery Indications for use: A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. Device Description: The proposed device, Latex Surgeon's Gloves (Powdered and Powder Free) is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, per standard ASTM D3577-0961, the rubber surgical gloves classification is: "Type I - gloves compounded primarily from natural rubber latex" . The proposed device includes Powdered and Powder Free Latex Surgeon's Gloves, and variations of different size. All variations share the same color, creamy white. The proposed device is provided radiation sterilized to achieve the Sterility Assurance Level (SAL) of 106 and place in a sterility maintenance package to ensure a shelf life of 3 years.
3. Predicate Device Identification
510(k) Number: K130301 Clearing date: August 22, 2013 Product Name: Latex Surgeon's Gloves (Powdered and Powder Free)
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Manufacturer: ELIMEDICAL DEVICES (FUJIAN) INC.
4. Performance Test Data Summary
• The Powdered Latex Surgeon's Gloves
| Characteristics | Dimension | Standard | Test Data |
|---|---|---|---|
| ASTM 3577-09e1 | |||
| Palm width | Size | (mm) | (mm) |
| 6 | 76±6 | 76~80 | |
| 61/2 | 83±6 | 82~88 | |
| 7 | 89±6 | 88~94 | |
| 71/2 | 95±6 | 99~101 | |
| 8 | 102±6 | 100~105 | |
| 81/2 | 108±6 | 107~111 | |
| 9 | 114±6 | 112~115 | |
| Overall Length | Size | (mm) | (mm) |
| 6 | 265 min | 267~272 | |
| 61/2 | 265 min | 271~275 | |
| 7 | 265 min | 272~278 | |
| 71/2 | 265 min | 272~281 | |
| 8 | 265 min | 278~282 | |
| 81/2 | 265 min | 280~284 | |
| 9 | 265 min | 286~289 | |
| Finger Thickness | Size | (mm) | (mm) |
| 6 | 0.10 min | 0.10~0.12 | |
| 61/2 | 0.10 min | 0.10~0.13 | |
| 7 | 0.10 min | 0.11~0.13 | |
| 71/2 | 0.10 min | 0.10~0.13 | |
| 8 | 0.10 min | 0.10~0.13 | |
| 81/2 | 0.10 min | 0.10~0.12 | |
| 9 | 0.10 min | 0.10~0.13 | |
| Palm Thickness | Size | (mm) | (mm) |
| 6 | 0.10 min | 0.10~0.12 | |
| 61/2 | 0.10 min | 0.10~0.13 | |
| 7 | 0.10 min | 0.11~0.13 | |
| 71/2 | 0.10 min | 0.10~0.13 | |
| 8 | 0.10 min | 0.10~0.13 | |
| 81/2 | 0.10 min | 0.11~0.13 | |
| 9 | 0.10 min | 0.11~0.13 | |
| Cuff thickness | Size | (mm) | (mm) |
| 6 | 0.10 min | 0.10~0.12 | |
| 61/2 | 0.10 min | 0.10~0.12 | |
| 7 | 0.10 min | 0.11~0.13 | |
| 71/2 | 0.10 min | 0.10~0.13 | |
| 8 | 0.10 min | 0.10~0.12 | |
| 81/2 | 0.10 min | 0.10~0.13 | |
| 9 | 0.10 min | 0.10~0.13 | |
| Physical Properties | ASTM 3577-09e1 | ||
| Before Aging | After aging at 70±2 °C166±2 hrs | ||
| - Tensile Strength | 24MPa,min | 18MPa,min | |
| - Ultimate Elongation | 750% min | 560% min | |
| - Stress at 500%Elongation | 5.5MPa,max | -- | |
| Freedom from Holes | ASTM D5151-11 | ||
| Passed Standard Acceptance CriteriaHoles at Inspection Level I, AQL 1.5 | |||
| Powder Amount | ASTM D6124-11, ≤ 15mg/dm² | ||
| 1.43 mg/dm², Meets ASTMD6124-06(Reapproved 2011), Results generatedvalues below 15mg/dm² of Powder amount | |||
| Protein Content | ASTM D5712-10, ≤200µg/dm² Aqueousextractable protein | ||
| Aqueous extractable protein: 132 mcg /dm²,Meets ASTM D5712-10, Results generatedvalues below 200µg/dm² of aqueous extractableprotein content | |||
| Biocompatibility | Primary Skin Irritation in rabbits ISO10993-10:2010-08-01 | ||
| Under the condition of the test, not an irritant. | |||
| Dermal sensitization in the guinea pig ISO10993-10:2010-08-01 | |||
| Under the condition of the test, not a sensitizer. | |||
| SterilizationValidation | ISO 11137-1:2006Sterility Assurance Level (SAL) of 10-6 |
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• The Powder-free Latex Surgeon's Gloves
| Characteristics | Standard | Test Data | ||
|---|---|---|---|---|
| Dimension | ASTM 3577-09e1 | |||
| Palm width | Size | (mm) | (mm) | |
| 6 | $76\pm6$ | 76~81 | ||
| 61/2 | $83\pm6$ | 81~87 | ||
| 7 | $89\pm6$ | 87~93 | ||
| 71/2 | $95\pm6$ | 99~101 | ||
| 8 | $102\pm6$ | 100~104 | ||
| 81/2 | $108\pm6$ | 106~110 | ||
| 9 | $114\pm6$ | 111~115 | ||
| Overall Length | Size | (mm) | (mm) | |
| 6 | 265 min | 268~275 | ||
| 61/2 | 265 min | 270~276 | ||
| 7 | 265 min | 270~278 | ||
| 71/2 | 265 min | 272~281 | ||
| 8 | 265 min | 278~284 | ||
| 81/2 | 265 min | 280~285 | ||
| 9 | 265 min | 284~289 | ||
| Finger Thickness | Size | (mm) | (mm) | |
| 6 | 0.10 min | 0.10~0.12 | ||
| 61/2 | 0.10 min | 0.10~0.12 | ||
| 7 | 0.10 min | 0.11~0.12 | ||
| 71/2 | 0.10 min | 0.10~0.13 | ||
| 8 | 0.10 min | 0.10~0.12 | ||
| 81/2 | 0.10 min | 0.10~0.12 | ||
| 9 | 0.10 min | 0.10~0.13 | ||
| Palm Thickness | Size | (mm) | (mm) | |
| 6 | 0.10 min | 0.10~0.13 | ||
| 61/2 | 0.10 min | 0.10~0.13 | ||
| 7 | 0.10 min | 0.10~0.12 | ||
| 71/2 | 0.10 min | 0.10~0.13 | ||
| 8 | 0.10 min | 0.11~0.12 | ||
| 81/2 | 0.10 min | 0.11~0.12 | ||
| 9 | 0.10 min | 0.10~0.12 | ||
| Cuff thickness | Size | (mm) | (mm) | |
| 6 | 0.10 min | 0.10~0.12 | ||
| 61/2 | 0.10 min | 0.10~0.12 | ||
| 7 | 0.10 min | 0.10~0.12 | ||
| 71/2 | 0.10 min | 0.10~0.13 | ||
| 8 | 0.10 min | 0.10~0.12 | ||
| 81/2 | 0.10 min | 0.10~0.12 | ||
| 9 | 0.10 min | 0.10~0.12 | ||
| Physical Properties | ASTM 3577-09e1 | |||
| Before Aging | After aging at 70±2 °C166±2 hrs | Before Aging | After aging at 70±2 °C166±2 hrs | |
| - Tensile Strength | 24MPa,min | 18MPa,min | 24.1-40.8Mpa | 20.8-27.4Mpa |
| - Ultimate Elongation | 750% min | 560% min | 961%-1239% | 761%-1103% |
| - Stress at 500%Elongation | 5.5MPa,max | -- | 4.3~4.7Mpa | -- |
| Freedom from Holes | ASTM D5151-11 | Passed Standard Acceptance CriteriaHoles at Inspection Level I, AQL 1.5 | ||
| Powder residue | ASTM D6124-11, ≤2mg/glove | 0.6 mg/glove, Meets ASTMD6124-06(Reapproved 2011),Results generatedvalues below 2mg of residual powder | ||
| Protein Content | ASTM D5712-10, ≤200µg/dm² Aqueousextractable protein | Aqueous extractable protein:61.6 mcg/dm²,Meets ASTM D5712-10, Results generatedvalues below 200µg/dm² of Aqueous extractableprotein content |
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Image /page/7/Picture/1 description: The image shows a logo with a stylized design. The logo features a combination of blue and green elements. On the left side, there is a blue semi-circle. To the right of the semi-circle, there are several curved green lines that resemble blades of grass or stylized leaves. The overall design is simple and modern.
| Biocompatibility | Primary Skin Irritation in rabbits ISO10993-10:2010-08-01 | Under the condition of the test, not an irritant. |
|---|---|---|
| Dermal sensitization in the guinea pig ISO10993-10:2010-08-01 | Under the condition of the test, not a sensitizer. | |
| SterilizationValidation | ISO 11137-1:2006 | Sterility Assurance Level (SAL) of 10-6 |
5. Non-Clinical Test Conclusion
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 D3577-09e1, Standard Specification for Rubber Surgical Gloves
-
ASTM D5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves
-
- ASTM D6124-06, (Reaffirmation 2011) Standard Test Method for Residual Powder on Medical Gloves
-
ASTM D6499-12, Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products
-
ASTM D5712-10. Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method
-
ISO 11137-1:06, Sterilization of Health Care Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process For Medical Devices (Sterility) * ISO 11137-2:13, Sterilization of Health Care Products - Radiation - Part 2: Establishing the Sterilization Dose. (Sterility)
-
ASTM F1929-12, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration (Sterility)
-
ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials (Sterility)
-
ASTM F1608:09, Standard Test Method For Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) (Sterility)
-
ASTM D7161-05(Reapproved 2010),Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions
-
ISO 10993-10:10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (Biocompatibility)
6. Substantial Equivalent Based on Assessment of Clinical Performance Data:
Clinical data was not including in this submission.
7. Substantially Equivalent Comparison Conclusion
· For Powdered Latex Surgeon's Gloves
| Parameters | New Device | Predicate Device | |
|---|---|---|---|
| 1 | 510(k) Number | K150609 | K130301 |
| 2 | Marketingclearance date | -- | AUG 22,2013 |
| 3 | Device Name | Annuy Powdered Latex Surgeon's Gloves | Powdered Latex Surgeon's Gloves |
| 4 | Manufacturer | Anhui Anyu Latex Products Co., Ltd | ELIMEDICAL DEVICES (FUJIAN) INC. |
| 5 | Product Code | KGO | KGO |
| 6 | Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 |
| 7 | Class | I | I |
| 8 | Device description | Annuy Powdered Latex Surgeon's Gloves areType I - gloves compounded primarily fromnatural rubber latex, and variations of differentsize. All variations share the same color,creamy white. | Powdered Latex Surgeon's Gloves are TypeI - gloves compounded primarily fromnatural rubber latex, and variations ofdifferent size. All variations share the samecolor, creamy white. |
| 9 | Intended use | A latex surgeon's glove is a device made ofnatural rubber intended to be worn byoperating room personnel to protect a surgicalwound from contamination. | A latex surgeon's glove is a device made ofnatural rubber intended to be worn byoperating room personnel to protect asurgical wound from contamination. |
| 10 | Material | Natural Rubber Latex | Natural Rubber Latex |
| 11 | Design | Single useSterile(Gamma radiation, SAL:10-6)PowderedCuffed | Single useSterile(Gamma radiation, SAL:10-6)PowderedCuffed |
| 12 | Size | Provided in sizes 6,61/2, 7, 71/2, 8, 81/2,9 | Provided in sizes 6,61/2, 7, 71/2, 8, 81/2,9 |
| 13 | Specifications | Powdered Latex Examination Gloves MeetASTM D3577-09e1 | Powdered Latex Examination Gloves MeetASTM D3577-09e1 |
| 14 | Dimensions- Overall Length | Meets ASTM D3577-09e1265mm min | Meets ASTM D3577-09e1265mm min |
| 15 | Dimensions- Palm Width | Meets ASTM D3577-09e16 76±6mm61/2 83±6mm7 89±6mm71/2 95±6mm8 102±6mm81/2 108±6mm9 114±6mm | Meets ASTM D3577-09e16 76±6mm61/2 83±6mm7 89±6mm71/2 95±6mm8 102±6mm81/2 108±6mm9 114±6mm |
| 16 | Dimensions- Finger Thickness | Meets ASTM D3577-09e10.10mm min | Meets ASTM D3577-09e10.10mm min |
| Dimensions- Palm Thickness | Meets ASTM D3577-09e10.10mm min | Meets ASTM D3577-09e10.10mm min | |
| Dimensions- Cuff Thickness | Meets ASTM D3577-09e10.10mm min | Meets ASTM D3577-09e10.10mm min | |
| 17 | Physical Properties | Meets ASTM D3577-09e1Before Aging:- Tensile Strength: 24Mpa min- Ultimate Elongation: 750% min- Stress at 500% Elongation: 5.5Mpa maxMeets ASTM D3578-10After aging at 70±2 oC 166±2 hrs:- Tensile Strength: 18Mpa min- Ultimate Elongation: 560% min | Meets ASTM D3577-09e1Before Aging:- Tensile Strength: 24Mpa min- Ultimate Elongation: 750% min- Stress at 500% Elongation: 5.5Mpa maxMeets ASTM D3578-10After aging at 70±2 oC 166±2 hrs:- Tensile Strength: 18Mpa min- Ultimate Elongation: 560% min |
| 18 | Freedom from | Meets ASTM D3577-09e1 and ASTM | Meets ASTM D3577-09e1 and ASTM |
| EAST QINJI ROAD & NORTH XINGHUA ROAD, BENGBU, ANHUI, CHINA | |||
| Holes | D5151-11 | D5151-11 | |
| Holes at Inspection Level I, AQL 1.5 | Holes at Inspection Level I, AQL 1.5 | ||
| 19 | Powder Amount | Meets ASTM D6124-11Below 15mg/dm² of residual powder | Meets ASTM D6124-11Below 15mg/dm² of residual powder |
| 20 | Protein Content | Meets ASTM D5712-10,Below 200µg/dm² of aqueous extractableprotein content | Meets ASTM D5712-10,Below 200µg/dm² of aqueous extractableprotein content |
| 21 | Absorbable donningor dusting powder | Cornstarch,Powdered with absorbable dusting powder,U.S.P. | Cornstarch,Powdered with absorbable dusting powder,U.S.P. |
| 22 | Biocompatibility | Meets ISO 10993-10:2010;Skin Irritation: Under the condition of thetest, not an irritant.Skin Sensitization: Under the condition of thetest, not a sensitizer. | Meets ISO 10993-10:2010;Skin Irritation: Under the condition of thetest, not an irritant.Skin Sensitization: Under the condition ofthe test, not a sensitizer. |
| 23 | Color | Creamy white, no colorant | Creamy white, no colorant |
| 24 | Labeling Features | Include the required labeling:• Surgical Gloves• Sterile• Single Use Only• Powdered• Natural rubber latex• Device color: Creamy white• Allergy warning• Contents, Size, REF, Lot Number, MFGdate, expiration data• Storage conditions• Manufacturer Name and Address | Include the required labeling:• Surgical Gloves• Sterile• Single Use Only• Powdered• Natural rubber latex• Device color: Creamy white• Allergy warning• Contents, Size, Lot Number, MFG date• Storage conditions• Manufacturer and distributor Name andAddress |
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Image /page/8/Picture/1 description: The image shows a logo with a circular design. The left half of the circle is blue, while the right half is green. Within the green portion, there are several curved lines that resemble blades of grass or leaves. The background is a light blue gradient.
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Image /page/9/Picture/1 description: The image shows a logo with a stylized design. The logo features a circular shape with two distinct sections. The upper section is colored in a light blue hue, while the lower section is in a darker green shade. Within the logo, there are curved lines that resemble a plant or a wave, adding a dynamic and organic feel to the design.
• For Powder-free Latex Surgeon's Gloves
| Parameters | New Device | Predicate Device | |
|---|---|---|---|
| 1 | 510(k) Number | K150609 | K130301 |
| 2 | Marketing clearance date | -- | AUG 22,2013 |
| 3 | Device Name | Annuy Powder-free Latex Surgeon's Gloves | Powder-free Latex Surgeon's Gloves |
| 4 | Manufacturer | Anhui Anyu Latex Products Co., Ltd | ELIMEDICAL DEVICES (FUJIAN) INC. |
| 5 | Product Code | KGO | KGO |
| 6 | Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 |
| 7 | Class | I | I |
| 8 | Device description | Annuy Powder-free Latex Surgeon's Gloves are Type I - gloves compounded primarily from natural rubber latex, and variations of different size. All variations share the same color, creamy white. | Powder-free Latex Surgeon's Gloves are Type I - gloves compounded primarily from natural rubber latex, and variations of different size. All variations share the same color, creamy white. |
| 9 | Intended use | A latex surgeon's glove is a device made of | A latex surgeon's glove is a device made of |
| natural rubber intended to be worn byoperating room personnel to protect a surgicalwound from contamination. | natural rubber intended to be worn byoperating room personnel to protect a surgicalwound from contamination. | ||
| 10 | Material | Natural Rubber Latex | Natural Rubber Latex |
| 11 | Design | Single useSterile(Gamma radiation, SAL:10-6)Powder-freeCuffed | Single useSterile(Gamma radiation, SAL:10-6)Powder-freeCuffed |
| 12 | Size | Provided in sizes 6,61/2, 7, 71/2, 8, 81/2,9 | Provided in sizes 6,61/2, 7, 71/2, 8, 81/2,9 |
| 13 | Specifications | Powdered Latex Examination Gloves MeetASTM D3577-09e1 | Powdered Latex Examination Gloves MeetASTM D3577-09e1 |
| 14 | Dimensions- Overall Length | Meets ASTM D3577-09e1265mm min | Meets ASTM D3577-09e1265mm min |
| 15 | Dimensions- Palm Width | Meets ASTM D3577-09e1 | 6 76±6mm61/2 83±6mm7 89±6mm71/2 95±6mm8 102±6mm81/2 108±6mm9 114±6mm |
| 16 | Dimensions- Finger Thickness | Meets ASTM D3577-09e10.10mm min | Meets ASTM D3577-09e10.10mm min |
| Dimensions- Palm Thickness | Meets ASTM D3577-09e10.10mm min | Meets ASTM D3577-09e10.10mm min | |
| Dimensions- Cuff Thickness | Meets ASTM D3577-09e10.10mm min | Meets ASTM D3577-09e10.10mm min | |
| 17 | Physical Properties | Meets ASTM D3577-09e1Before Aging:- Tensile Strength: 24Mpa min- Ultimate Elongation: 750% min- Stress at 500% Elongation: 5.5Mpa maxMeets ASTM D3578-10After aging at 70±2 °C 166±2 hrs:- Tensile Strength: 18Mpa min- Ultimate Elongation: 560% min | Meets ASTM D3577-09e1Before Aging:- Tensile Strength: 24Mpa min- Ultimate Elongation: 750% min- Stress at 500% Elongation: 5.5Mpa maxMeets ASTM D3578-10After aging at 70±2 °C 166±2 hrs:- Tensile Strength: 18Mpa min- Ultimate Elongation: 560% min |
| 18 | Freedom fromHoles | Meets ASTM D3577-09e1 and ASTMD5151-11Holes at Inspection Level I, AQL 1.5 | Meets ASTM D3577-09e1 and ASTMD5151-11Holes at Inspection Level I, AQL 1.5 |
| 19 | Powder residue | Meets ASTM D6124-11Below 2mg/glove of residual powder | Meets ASTM D6124-11Below 2mg/glove of residual powder |
| 20 | Protein Content | Meets ASTM D5712-10,Below 200µg/dm2 of aqueous extractable | Meets ASTM D5712-10,Below 200µg/dm2 of aqueous extractable |
| protein content | 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 10993-10:2010;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:• Surgical Gloves• Sterile• Single Use Only• Powder-free• Natural rubber latex• Device color: Creamy white• Allergy warning• Contents, Size, Lot Number, Lot Number, MFG date, expiration data• Storage conditions• Manufacturer Name and Address | Include the required labeling:• Surgical Gloves• Sterile• Single Use Only• Powder-free• Natural rubber latex• Device color: Creamy white• Allergy warning• Contents, Size, Lot Number, MFG date• Storage conditions• Manufacturer and distributor Name and Address |
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Image /page/10/Picture/1 description: The image shows a logo with a blue circle on the left side. Inside the circle, there are green, stylized shapes that resemble leaves or blades of grass. The green shapes are arranged in a way that suggests growth or movement, with the tallest shape in the center and smaller shapes on either side.
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Image /page/11/Picture/1 description: The image shows a logo with a circular shape. The left side of the circle is blue, while the right side features green lines that resemble blades of grass or leaves. The green lines are arranged in a fan-like pattern, creating a sense of growth or nature.
Discussion: Based on the above comparison, the Annuy Latex Surgeon's 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 D3577 and ISO10993-10 standards. From the tests, results generated values that,
Annuy Powdered Latex Surgeon's Gloves contain no more than 15mg/dm² powder and no more than 200µg/dm² extractable protein.
Annuy Powder-free Latex Surgeon's Gloves contain no more than 2mg/glove of residual powder and no more than 200ug/dm2 extractable protein.
Conclusion: The Annuy Latex Surgeon's Gloves (Powdered and Powder Free) manufactured by Anhui Anyu Latex Products Co., Ltd are substantially equivalent to the predicate device (K130301).
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).