Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and sterilization of latex gloves, with no mention of AI or ML.

Therapeutic

No
The device, a latex surgeon's glove, is intended for protection from contamination, not for treating a disease or condition.

Diagnostic

No
Explanation: The device is a latex surgeon's glove intended to protect a surgical wound from contamination, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states the device is made of natural rubber latex and describes physical characteristics and testing related to material properties and sterility, indicating it is a physical hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
Device Description: The description clearly states the device is a "Latex Surgeon's Glove" intended to be worn by operating room personnel to protect a surgical wound from contamination. This is a barrier device used on the body during a procedure, not for testing specimens.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing diagnostic information about a disease or condition.
- Using reagents or test kits.

The device described is a Class II medical device used for protection and barrier purposes during surgery.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

KGO

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 10-6 and place in a sterility maintenance package to ensure a shelf life of 3 years.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

operating room personnel

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 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)

For Powdered Latex Surgeon's Gloves:
Characteristics: Dimension (Palm width, Overall Length, Finger Thickness, Palm Thickness, Cuff thickness), Physical Properties (Tensile Strength, Ultimate Elongation, Stress at 500% Elongation), Freedom from Holes, Powder Amount, Protein Content, Biocompatibility (Primary Skin Irritation, Dermal sensitization), Sterilization Validation. Test data provided values within standard specifications.

For Powder-free Latex Surgeon's Gloves:
Characteristics: Dimension (Palm width, Overall Length, Finger Thickness, Palm Thickness, Cuff thickness), Physical Properties (Tensile Strength, Ultimate Elongation, Stress at 500% Elongation), Freedom from Holes, Powder residue, Protein Content, Biocompatibility (Primary Skin Irritation, Dermal sensitization), Sterilization Validation. Test data provided values within standard specifications.

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.

K130301

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

Regulation Number and Section

§ 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).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three faces overlapping to symbolize the department's focus on health and well-being. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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.

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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/1 description: The image shows a logo with a blue circle on the left side and a green design on the right side. The green design appears to be a stylized representation of leaves or feathers. The background is a light blue color, providing a soft contrast to the logo elements.

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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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
166±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 Criteria
Holes at Inspection Level I, AQL 1.5
Powder Amount	ASTM D6124-11, ≤ 15mg/dm²
	1.43 mg/dm², Meets ASTM
D6124-06(Reapproved 2011), Results generated
values below 15mg/dm² of Powder amount
Protein Content	ASTM D5712-10, ≤200µg/dm² Aqueous
extractable protein
	Aqueous extractable protein: 132 mcg /dm²,
Meets ASTM D5712-10, Results generated
values below 200µg/dm² of aqueous extractable
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.
Sterilization
Validation	ISO 11137-1:2006
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
166±2 hrs	Before Aging	After aging at 70±2 °C
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%
Elongation	5.5MPa,max	--	4.3~4.7Mpa	--

Freedom from Holes	ASTM D5151-11		Passed Standard Acceptance Criteria
Holes at Inspection Level I, AQL 1.5
Powder residue	ASTM D6124-11, ≤2mg/glove		0.6 mg/glove, Meets ASTM
D6124-06(Reapproved 2011),Results generated
values below 2mg of residual powder
Protein Content	ASTM D5712-10, ≤200µg/dm² Aqueous
extractable protein		Aqueous extractable protein:61.6 mcg/dm²,
Meets ASTM D5712-10, Results generated
values below 200µg/dm² of Aqueous extractable
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
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. |
| Sterilization
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
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
Type I - gloves compounded primarily from
natural rubber latex, and variations of different
size. All variations share the same color,
creamy white.	Powdered 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
natural rubber intended to be worn by
operating room personnel to protect a surgical
wound from contamination.	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.
10	Material	Natural Rubber Latex	Natural Rubber Latex
11	Design	Single use
Sterile(Gamma radiation, SAL:10-6)
Powdered
Cuffed	Single use
Sterile(Gamma radiation, SAL:10-6)
Powdered
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
ASTM D3577-09e1	Powdered Latex Examination Gloves Meet
ASTM D3577-09e1
14	Dimensions

Overall Length | Meets ASTM D3577-09e1
265mm min | Meets ASTM D3577-09e1
265mm min |
| 15 | Dimensions
Palm Width | Meets ASTM D3577-09e1
6 76±6mm
61/2 83±6mm
7 89±6mm
71/2 95±6mm
8 102±6mm
81/2 108±6mm
9 114±6mm | Meets ASTM D3577-09e1
6 76±6mm
61/2 83±6mm
7 89±6mm
71/2 95±6mm
8 102±6mm
81/2 108±6mm
9 114±6mm |
| 16 | Dimensions
Finger Thickness | Meets ASTM D3577-09e1
0.10mm min | Meets ASTM D3577-09e1
0.10mm min |
| | Dimensions
Palm Thickness | Meets ASTM D3577-09e1
0.10mm min | Meets ASTM D3577-09e1
0.10mm min |
| | Dimensions
Cuff Thickness | Meets ASTM D3577-09e1
0.10mm min | Meets ASTM D3577-09e1
0.10mm min |
| 17 | Physical Properties | Meets ASTM D3577-09e1
Before Aging:
Tensile Strength: 24Mpa min
Ultimate Elongation: 750% min
Stress at 500% Elongation: 5.5Mpa max
Meets ASTM D3578-10
After aging at 70±2 oC 166±2 hrs:
Tensile Strength: 18Mpa min
Ultimate Elongation: 560% min | Meets ASTM D3577-09e1
Before Aging:
Tensile Strength: 24Mpa min
Ultimate Elongation: 750% min
Stress at 500% Elongation: 5.5Mpa max
Meets ASTM D3578-10
After 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 D6124-11
Below 15mg/dm² of residual powder | Meets ASTM D6124-11
Below 15mg/dm² of residual powder |
| 20 | Protein Content | Meets ASTM D5712-10,
Below 200µg/dm² of aqueous extractable
protein content | Meets ASTM D5712-10,
Below 200µg/dm² of aqueous extractable
protein content |
| 21 | Absorbable donning
or 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 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
• Powdered
• Natural rubber latex
• Device color: Creamy white
• Allergy warning
• Contents, Size, REF, Lot Number, MFG
date, 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 and
Address |

8

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.

9

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
operating room personnel to protect a surgical
wound from contamination.	natural rubber intended to be worn by
operating room personnel to protect a surgical
wound from contamination.
10	Material	Natural Rubber Latex	Natural Rubber Latex
11	Design	Single use
Sterile(Gamma radiation, SAL:10-6)
Powder-free
Cuffed	Single use
Sterile(Gamma radiation, SAL:10-6)
Powder-free
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
ASTM D3577-09e1	Powdered Latex Examination Gloves Meet
ASTM D3577-09e1
14	Dimensions

Overall Length | Meets ASTM D3577-09e1
265mm min | Meets ASTM D3577-09e1
265mm min |
| 15 | Dimensions
Palm Width | Meets ASTM D3577-09e1 | 6             76±6mm
61/2            83±6mm
7             89±6mm
71/2            95±6mm
8             102±6mm
81/2           108±6mm
9             114±6mm |
| 16 | Dimensions
Finger Thickness | Meets ASTM D3577-09e1
0.10mm min | Meets ASTM D3577-09e1
0.10mm min |
| | Dimensions
Palm Thickness | Meets ASTM D3577-09e1
0.10mm min | Meets ASTM D3577-09e1
0.10mm min |
| | Dimensions
Cuff Thickness | Meets ASTM D3577-09e1
0.10mm min | Meets ASTM D3577-09e1
0.10mm min |
| 17 | Physical Properties | Meets ASTM D3577-09e1
Before Aging:
Tensile Strength: 24Mpa min
Ultimate Elongation: 750% min
Stress at 500% Elongation: 5.5Mpa max
Meets ASTM D3578-10
After aging at 70±2 °C 166±2 hrs:
Tensile Strength: 18Mpa min
Ultimate Elongation: 560% min | Meets ASTM D3577-09e1
Before Aging:
Tensile Strength: 24Mpa min
Ultimate Elongation: 750% min
Stress at 500% Elongation: 5.5Mpa max
Meets ASTM D3578-10
After aging at 70±2 °C 166±2 hrs:
Tensile Strength: 18Mpa min
Ultimate Elongation: 560% min |
| 18 | Freedom from
Holes | Meets ASTM D3577-09e1 and ASTM
D5151-11
Holes at Inspection Level I, AQL 1.5 | Meets ASTM D3577-09e1 and ASTM
D5151-11
Holes at Inspection Level I, AQL 1.5 |
| 19 | Powder residue | Meets ASTM D6124-11
Below 2mg/glove of residual powder | Meets ASTM D6124-11
Below 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 |

10

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.

11

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).