Annuy Latex Surgeon's Gloves (Powdered and Powder Free)

K150609 · Anhui Anyu Latex Products Co., Ltd. · KGO · Nov 16, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K150609
• Device Name: Annuy Latex Surgeon's Gloves (Powdered and Powder Free)
• Applicant: Anhui Anyu Latex Products Co., Ltd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Nov 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended 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 Story

Sterile, disposable natural rubber latex gloves; intended for use by operating room personnel to protect surgical wounds from contamination. Device provided in powdered and powder-free versions; powder-free version utilizes polyurethane and polyacrylic acid coating on the inner surface to facilitate donning. Gloves are radiation-sterilized to a Sterility Assurance Level (SAL) of 10^-6. Healthcare providers wear the gloves during surgical procedures to maintain a sterile field and prevent cross-contamination between the clinician and the patient. Benefits include barrier protection against contaminants during surgery.

Clinical Evidence

No clinical data included. Evidence consists of bench testing for physical properties (tensile strength, elongation), freedom from holes (ASTM D5151), residual powder (ASTM D6124), protein content (ASTM D5712), and biocompatibility (ISO 10993-10).

Technological Characteristics

Natural rubber latex; Type I classification per ASTM D3577-09e1. Powder-free version includes polyurethane and polyacrylic acid inner coating. Sterilization via gamma radiation (SAL 10^-6). Complies with ASTM D3577, D5151, D6124, D5712, and ISO 10993-10.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination. No specific patient population, age, or gender restrictions are defined.

Regulatory Classification

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.

Predicate Devices

• Latex Surgeon's Gloves (Powdered and Powder Free) (K130301)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 [e-mail] Tel: [phone]

#### 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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Image /page/4/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. Inside the circle, there are curved lines that resemble a plant or a wave. The lines are green and appear to be growing or flowing from the bottom of the circle towards the top.

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 °C<br>166±2 hrs | |
| - Tensile Strength | 24MPa,min | 18MPa,min | |
| - Ultimate Elongation | 750% min | 560% min | |
| - Stress at 500%<br>Elongation | 5.5MPa,max | -- | |
| Freedom from Holes | ASTM D5151-11 | | |
| | Passed Standard Acceptance Criteria<br>Holes at Inspection Level I, AQL 1.5 | | |
| Powder Amount | ASTM D6124-11, ≤ 15mg/dm² | | |
| | 1.43 mg/dm², Meets ASTM<br>D6124-06(Reapproved 2011), Results generated<br>values below 15mg/dm² of Powder amount | | |
| Protein Content | ASTM D5712-10, ≤200µg/dm² Aqueous<br>extractable protein | | |
| | Aqueous extractable protein: 132 mcg /dm²,<br>Meets ASTM D5712-10, Results generated<br>values below 200µg/dm² of aqueous extractable<br>protein content | | |
| Biocompatibility | Primary Skin Irritation in rabbits ISO<br>10993-10:2010-08-01 | | |
| | Under the condition of the test, not an irritant. | | |
| | Dermal sensitization in the guinea pig ISO<br>10993-10:2010-08-01 | | |
| | Under the condition of the test, not a sensitizer. | | |
| Sterilization<br>Validation | ISO 11137-1:2006<br>Sterility Assurance Level (SAL) of 10-6 | | |

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Image /page/5/Picture/1 description: The image shows a logo with a stylized design. The logo features a blue semi-circle at the top, with green curved lines extending upwards from the bottom, resembling blades of grass or stylized waves. The overall design is simple and modern, with a focus on natural elements.

## • 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 °C<br>166±2 hrs | Before Aging | After aging at 70±2 °C<br>166±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%<br>Elongation | 5.5MPa,max | -- | 4.3~4.7Mpa | -- |
| | | | | |
| Freedom from Holes | ASTM D5151-11 | | Passed Standard Acceptance Criteria<br>Holes at Inspection Level I, AQL 1.5 | |
| Powder residue | ASTM D6124-11, ≤2mg/glove | | 0.6 mg/glove, Meets ASTM<br>D6124-06(Reapproved 2011),Results generated<br>values below 2mg of residual powder | |
| Protein Content | ASTM D5712-10, ≤200µg/dm² Aqueous<br>extractable protein | | Aqueous extractable protein:61.6 mcg/dm²,<br>Meets ASTM D5712-10, Results generated<br>values below 200µg/dm² of Aqueous extractable<br>protein content | |

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Image /page/6/Picture/1 description: The image shows a logo with a circular shape. The logo is divided into two main sections: a blue upper section and a green lower section. The green section features a stylized representation of plant leaves or blades of grass, creating a natural or environmental feel. The overall design is simple and modern, suggesting a focus on nature, growth, or sustainability.

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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 ISO<br>10993-10:2010-08-01 | Under the condition of the test, not an irritant. |
|-----------------------------|-------------------------------------------------------------------|----------------------------------------------------|
| | Dermal sensitization in the guinea pig ISO<br>10993-10:2010-08-01 | Under the condition of the test, not a sensitizer. |
| Sterilization<br>Validation | 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 | Marketing<br>clearance 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 are<br>Type I - gloves compounded primarily from<br>natural rubber latex, and variations of different<br>size. All variations share the same color,<br>creamy white. | Powdered Latex Surgeon's Gloves are Type<br>I - gloves compounded primarily from<br>natural rubber latex, and variations of<br>different size. All variations share the same<br>color, creamy white. |
| 9 | Intended use | A latex surgeon's glove is a device made of<br>natural rubber intended to be worn by<br>operating room personnel to protect a surgical<br>wound from contamination. | A latex surgeon's glove is a device made of<br>natural rubber intended to be worn by<br>operating room personnel to protect a<br>surgical wound from contamination. |
| 10 | Material | Natural Rubber Latex | Natural Rubber Latex |
| 11 | Design | Single use<br>Sterile(Gamma radiation, SAL:10-6)<br>Powdered<br>Cuffed | Single use<br>Sterile(Gamma radiation, SAL:10-6)<br>Powdered<br>Cuffed |
| 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 Meet<br>ASTM D3577-09e1 | Powdered Latex Examination Gloves Meet<br>ASTM D3577-09e1 |
| 14 | Dimensions<br>- Overall Length | Meets ASTM D3577-09e1<br>265mm min | Meets ASTM D3577-09e1<br>265mm min |
| 15 | Dimensions<br>- Palm Width | Meets ASTM D3577-09e1<br>6 76±6mm<br>61/2 83±6mm<br>7 89±6mm<br>71/2 95±6mm<br>8 102±6mm<br>81/2 108±6mm<br>9 114±6mm | Meets ASTM D3577-09e1<br>6 76±6mm<br>61/2 83±6mm<br>7 89±6mm<br>71/2 95±6mm<br>8 102±6mm<br>81/2 108±6mm<br>9 114±6mm |
| 16 | Dimensions<br>- Finger Thickness | Meets ASTM D3577-09e1<br>0.10mm min | Meets ASTM D3577-09e1<br>0.10mm min |
| | Dimensions<br>- Palm Thickness | Meets ASTM D3577-09e1<br>0.10mm min | Meets ASTM D3577-09e1<br>0.10mm min |
| | Dimensions<br>- Cuff Thickness | Meets ASTM D3577-09e1<br>0.10mm min | Meets ASTM D3577-09e1<br>0.10mm min |
| 17 | Physical Properties | Meets ASTM D3577-09e1<br>Before Aging:<br>- Tensile Strength: 24Mpa min<br>- Ultimate Elongation: 750% min<br>- Stress at 500% Elongation: 5.5Mpa max<br>Meets ASTM D3578-10<br>After aging at 70±2 oC 166±2 hrs:<br>- Tensile Strength: 18Mpa min<br>- Ultimate Elongation: 560% min | Meets ASTM D3577-09e1<br>Before Aging:<br>- Tensile Strength: 24Mpa min<br>- Ultimate Elongation: 750% min<br>- Stress at 500% Elongation: 5.5Mpa max<br>Meets ASTM D3578-10<br>After aging at 70±2 oC 166±2 hrs:<br>- Tensile Strength: 18Mpa min<br>- 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 D6124-11<br>Below 15mg/dm² of residual powder | Meets ASTM D6124-11<br>Below 15mg/dm² of residual powder |
| 20 | Protein Content | Meets ASTM D5712-10,<br>Below 200µg/dm² of aqueous extractable<br>protein content | Meets ASTM D5712-10,<br>Below 200µg/dm² of aqueous extractable<br>protein content |
| 21 | Absorbable donning<br>or dusting powder | Cornstarch,<br>Powdered with absorbable dusting powder,<br>U.S.P. | Cornstarch,<br>Powdered with absorbable dusting powder,<br>U.S.P. |
| 22 | Biocompatibility | Meets ISO 10993-10:2010;<br><b>Skin Irritation:</b> Under the condition of the<br>test, not an irritant.<br><b>Skin Sensitization:</b> Under the condition of the<br>test, not a sensitizer. | Meets ISO 10993-10:2010;<br><b>Skin Irritation:</b> Under the condition of the<br>test, not an irritant.<br><b>Skin Sensitization:</b> Under the condition of<br>the test, not a sensitizer. |
| 23 | Color | Creamy white, no colorant | Creamy white, no colorant |
| 24 | Labeling Features | Include the required labeling:<br>• Surgical Gloves<br>• Sterile<br>• Single Use Only<br>• Powdered<br>• Natural rubber latex<br>• Device color: Creamy white<br>• Allergy warning<br>• Contents, Size, REF, Lot Number, MFG<br>date, expiration data<br>• Storage conditions<br>• Manufacturer Name and Address | Include the required labeling:<br>• Surgical Gloves<br>• Sterile<br>• Single Use Only<br>• Powdered<br>• Natural rubber latex<br>• Device color: Creamy white<br>• Allergy warning<br>• Contents, Size, Lot Number, MFG date<br>• Storage conditions<br>• Manufacturer and distributor Name and<br>Address |

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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 by<br>operating room personnel to protect a surgical<br>wound from contamination. | natural rubber intended to be worn by<br>operating room personnel to protect a surgical<br>wound from contamination. |
| 10 | Material | Natural Rubber Latex | Natural Rubber Latex |
| 11 | Design | Single use<br>Sterile(Gamma radiation, SAL:10-6)<br>Powder-free<br>Cuffed | Single use<br>Sterile(Gamma radiation, SAL:10-6)<br>Powder-free<br>Cuffed |
| 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 Meet<br>ASTM D3577-09e1 | Powdered Latex Examination Gloves Meet<br>ASTM D3577-09e1 |
| 14 | Dimensions<br>- Overall Length | Meets ASTM D3577-09e1<br>265mm min | Meets ASTM D3577-09e1<br>265mm min |
| 15 | Dimensions<br>- Palm Width | Meets ASTM D3577-09e1 | 6             76±6mm<br>61/2            83±6mm<br>7             89±6mm<br>71/2            95±6mm<br>8             102±6mm<br>81/2           108±6mm<br>9             114±6mm |
| 16 | Dimensions<br>- Finger Thickness | Meets ASTM D3577-09e1<br>0.10mm min…