Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free)

• K Number: K150612
• Device Name: Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free)
• Manufacturer: ANHUI ANYU LATEX PRODUCTS CO., LTD
• Date Cleared: 2015-11-16 ( 251 days)
• Product Code: LYY , LYZ
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: K072145
• Predicate For: N/A

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

Device Description

Annuy Latex Patient Examination Glove (powdered and powder-free) is a glove made from natural rubber that covers the hand up to the wrist. It is cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. It has three sizes, i.e., large, medium, and small. All variations share the same natural color, creamy white. The glove is non-sterile and is for single use only, to be discarded after each examination is performed. It acts as a barrier between the examiner and the subject being examined in order to prevent contamination between them.

Annuy Nitrile Patient Examination Glove (powdered and powder-free) is a glove made from nitrile butadiene rubber Latex that covers the hand up to the wrist. It is cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. It has three sizes, i.e. large, medium, and small. All variations share the same blue color. The glove is non-sterile and is for single use only, to be discarded after each examination is performed. It acts as a barrier between the examiner and the subject being examined in order to prevent contamination between them.

AI/ML Overview

The provided documents detail the acceptance criteria and performance study for four types of examination gloves: Powdered Latex, Powder-free Latex, Powdered Nitrile, and Powder-free Nitrile.

1. Table of Acceptance Criteria and Reported Device Performance

Device: Annuy Latex Patient Examination Gloves (Powdered)

Characteristics	Standard	Acceptance Criteria (Standard)	Reported Device Performance
Dimension	ASTM D3578-10
Palm width		Small: 80±10 mm	Medium: 95±10 mm
Overall Length		Small: 220 min mm	Medium: 230 min mm
Finger Thickness		0.08 min mm	0.09~0.12 mm (across sizes)
Palm Thickness		0.08 min mm	0.09~0.12 mm (across sizes)
Physical Properties	ASTM D3578-10
Before Aging
- Tensile Strength		18 Mpa min	20.3~35.1 Mpa
- Ultimate Elongation		650% min	961~1233%
- Stress at 500% Elongation		5.5 Mpa max	4.6~5.4 Mpa
After aging at 70±2 °C, 166±2 hrs
- Tensile Strength		14 Mpa min	16.7~24.0 Mpa
- Ultimate Elongation		500% min	748~1021%
Freedom from Holes	ASTM D5151-11	Inspection Level I, AQL 2.5	Passed Standard Acceptance Criteria
Powder Amount	ASTM D6124-11	≤ 10 mg/dm²	2.34 mg/dm²
Protein Content	ASTM D5712-10	≤ 200 µg/dm² Aqueous extractable protein	72.1 mcg/dm²
Biocompatibility	ISO 10993-10:2010-08-01
Primary Skin Irritation		Not an irritant	Not an irritant
Dermal sensitization		Not a sensitizer	Not a sensitizer

Device: Annuy Latex Patient Examination Gloves (Powder-free)

Characteristics	Standard	Acceptance Criteria (Standard)	Reported Device Performance
Dimension	ASTM D3578-10
Palm width		Small: 80±10 mm	Medium: 95±10 mm
Overall Length		Small: 220 min mm	Medium: 230 min mm
Finger Thickness		0.08 min mm	0.09~0.12 mm (across sizes)
Palm Thickness		0.08 min mm	0.08~0.12 mm (across sizes)
Physical Properties	ASTM D3578-10
Before Aging
- Tensile Strength		18 Mpa min	18.4~32.3 Mpa
- Ultimate Elongation		650% min	955~1148%
- Stress at 500% Elongation		5.5 Mpa max	4.8~5.4 Mpa
After aging at 70±2 °C, 166±2 hrs
- Tensile Strength		14 Mpa min	18.7~24.5 Mpa
- Ultimate Elongation		500% min	797~976%
Freedom from Holes	ASTM D5151-11	Inspection Level I, AQL 2.5	Passed Standard Acceptance Criteria
Powder residue	ASTM D6124-11	≤ 2 mg/glove	0.68 mg/glove
Protein Content	ASTM D5712-10	≤ 200 µg/dm² Aqueous extractable protein	70.8 mcg/dm²
Biocompatibility	ISO 10993-10:2010-08-01
Primary Skin Irritation		Not an irritant	Not an irritant
Dermal sensitization		Not a sensitizer	Not a sensitizer

Device: Annuy Nitrile Patient Examination Gloves (Powdered)

Characteristics	Standard	Acceptance Criteria (Standard)	Reported Device Performance
Dimension	ASTM D6319-10
Palm width		Small: 80±10 mm	Medium: 95±10 mm
Overall Length		Small: 220 min mm	Medium: 230 min mm
Finger Thickness		0.05 min mm	0.08 mm (across sizes)
Palm Thickness		0.05 min mm	0.08 mm (across sizes)
Physical Properties	ASTM D6319-10
Before Aging
- Tensile Strength		14 Mpa min	17.5~31.1 Mpa
- Ultimate Elongation		500% min	761~948%
After aging at 70±2 °C, 166±2 hrs
- Tensile Strength		14 Mpa min	15.7~18.5 Mpa
- Ultimate Elongation		400% min	421~839%
Freedom from Holes	ASTM D5151-11	Inspection Level G-1, AQL 2.5	Passed Standard Acceptance Criteria
Powder Amount	ASTM D6124-11	≤ 10 mg/dm²	1.86 mg/dm²
Biocompatibility	ISO 10993-10:2010-08-01
Primary Skin Irritation		Not an irritant	Not an irritant
Dermal sensitization		Not a sensitizer	Not a sensitizer

Device: Annuy Nitrile Patient Examination Gloves (Powder-free)

Characteristics	Standard	Acceptance Criteria (Standard)	Reported Device Performance
Dimension	ASTM D6319-10
Palm width		Small: 80±10 mm	Medium: 95±10 mm
Overall Length		Small: 220 min mm	Medium: 230 min mm
Finger Thickness		0.05 min mm	0.08 mm (across sizes)
Palm Thickness		0.05 min mm	0.08 mm (across sizes)
Physical Properties	ASTM D6319-10
Before Aging
- Tensile Strength		14 Mpa min	18.8~29.5 Mpa
- Ultimate Elongation		500% min	745~945%
After aging at 70±2 °C, 166±2 hrs
- Tensile Strength		14 Mpa min	16.2~21.0 Mpa
- Ultimate Elongation		400% min	445~773%
Freedom from Holes	ASTM D5151-11	Inspection Level G-1, AQL 2.5	Passed Standard Acceptance Criteria
Powder residue	ASTM D6124-11	≤ 2 mg/glove	0.72 mg/glove
Biocompatibility	ISO 10993-10:2010-08-01
Primary Skin Irritation		Not an irritant	Not an irritant
Dermal sensitization		Not a sensitizer	Not a sensitizer

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact "sample size used for the test set" (i.e., the number of individual gloves tested for each characteristic). However, it references specific ASTM and ISO standards that govern testing procedures for these types of gloves. These standards typically define sampling plans, AQL (Acceptable Quality Level) for certain tests (like freedom from holes), or specify the number of specimens for physical property testing. For example, for "Freedom from Holes," AQL values are given (2.5 for Inspection Level I for latex, 2.5 for Inspection Level G-1 for nitrile), implying a sampling plan was followed.

The data provenance is Anhui Anyu Latex Products Co., Ltd in Bengbu, Anhui, China, as they are the manufacturer and submitter of the 510(k) premarket notification. The data appears to be from retrospective testing conducted by the manufacturer to demonstrate compliance with the referenced standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This section is not applicable as the described tests are laboratory-based, objective performance measures (e.g., dimensions, physical properties, chemical residue, biocompatibility) of physical devices (gloves) against established engineering and safety standards. They do not involve interpretation of complex data (like medical images) by human experts to establish ground truth in the way medical AI or diagnostic devices would.

4. Adjudication Method for the Test Set

This is not applicable for the same reason as point 3. The assessment criteria are derived from objective measurements against specified standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical data was not included in this submission." The evaluation focused entirely on technical and physical performance metrics of the gloves against recognized standards.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a patient examination glove, a physical product, not an algorithm or AI system. Therefore, the concept of a "standalone" algorithmic performance is irrelevant. The tests performed are standalone in the sense that they assess the intrinsic properties of the glove material and manufacturing.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation is based on established industry standards and regulatory requirements. Specifically, these include:

• ASTM (American Society for Testing and Materials) Standards:
  • ASTM D3578-10 (Standard Specification for Rubber Examination Gloves)
  • ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application)
  • ASTM D5151-11 (Standard Test Method for Detection of Holes in Medical Gloves)
  • ASTM D6124-11 (Standard Test Method for Residual Powder on Medical Gloves)
  • ASTM D5712-10 (Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber Products Using the Modified Lowry Method)
• ISO (International Organization for Standardization) Standard:
  • ISO 10993-10 (Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization)

These standards define the acceptable ranges or thresholds for various physical, chemical, and biological properties of examination gloves.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product (medical glove), not an AI/ML model that requires a training set. The manufacturing process of the gloves would involve quality control and process monitoring, but this is distinct from training a software algorithm.

9. How the Ground Truth for the Training Set was Established

This is not applicable as there is no training set for a physical medical device like an examination glove.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 16, 2015

Anhui Anyu Latex Products Co., Ltd. c/o Doris Dong Shanghai CV Technology Co., Ltd. Room 1706. No. 128 Songle Rd., Songjiang Area Shanghai 201600 CHINA

Re: K150612 Trade/Device Name: "Annuy Latex Patient Examination Glove (Powdered and Powder-free)" & "Annuy Nitrile Patient Examination Glove (Powdered and Powder-free)" Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: Class I Product Code: LYY, LYZ Dated: October 4, 2015 Received: October 16, 2015

Dear Ms. Dong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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) K150612

Device Name

Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free)

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Section 5 510(k) Summary

[As required by 21 CFR 807.92]

1. Submission Information:

510(k) Number:	K150612
Date:	Sept 30th, 2015
Type of 510(k) Submission:	Traditional
Basis for 510(k) Submission:	New device
Submitter/Manufacturer:	Anhui Anyu Latex Products Co., LtdEast 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 ChinaE-mail: [e-mail]: [phone] / Fax: [phone]

2. Device Description:

Proprietary Name:	Annuy Latex Patient Examination Glove (powdered and powder-free);Annuy Nitrile Patient Examination Glove (powdered and powder-free)
Common Name:	Latex Examination Gloves (powdered and powder free);Nitrile Examination Gloves (powdered and powder free)
Classification Name:	Glove, patient examination, latex;Glove, patient examination, poly
Product Code:	LYY & LZA
Device Class:	I
Regulation Number:	21 CFR 880.6250
Review Panel:	General Hospital
Indications for use:	A patient examination glove is a disposable device intended for medical purposes thatis worn on the examiner's hand or fingers to prevent contamination between patient andexaminer

Device Description:

Annuy Latex Patient Examination Glove (powdered and powder-free) is a glove made from natural rubber that covers the hand up to the wrist. It is cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. It has three sizes, i.e., large, medium, and small. All variations share the same natural color, creamy white. The glove is non-sterile and is for single use only, to be discarded after each examination is performed. It acts as a barrier between the examiner and the subject being examined in order to prevent contamination between them.

Annuy Nitrile Patient Examination Glove (powdered and powder-free) is a glove made from nitrile butadiene rubber Latex that covers the hand up to the wrist. It is cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. It has three sizes, i.e. large, medium, and small. All variations share the same blue color. The glove is non-sterile and is for single use only, to be discarded after each examination is performed. It acts as a barrier between the examiner and the subject being examined in order to prevent contamination between them.

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Image /page/4/Picture/1 description: The image shows a logo with a circular shape. The top half of the circle is blue, and the bottom half is green. There are several curved lines in the center of the circle, resembling a plant or a bird's wing. The logo is simple and clean, with a focus on natural elements.

3. Predicate Device Identification

510(k) Number: K072145

Product Name:

Latex Examination Gloves (Powdered and Powder-Free)

Nitrile Examination Gloves (Powdered and Powder-Free)

Manufacturer: Zhanjiang Jiali Glove Products Co., LTD

4. Performance Test Data Summary

• The Powdered Latex Patient Examination Gloves

Characteristics	Standard		Test Data
Dimension	ASTM D3578-10
Palm width	Size	(mm)	(mm)
	Small	80±10	80~84
	Medium	95±10	93~97
	Large	111±10	107~109
Overall Length	Size	(mm)	(mm)
	Small	220 min	240~246
	Medium	230 min	241~248
	Large	230 min	240~249
Finger Thickness	Size	(mm)	(mm)
	Small	0.08 min	0.09~0.11
	Medium	0.08 min	0.09~0.11
	Large	0.08 min	0.09~0.12
Palm Thickness	Size	(mm)	(mm)
	Small	0.08 min	0.10~0.12
	Medium	0.08 min	0.10~0.12
	Large	0.08 min	0.09~0.12
Physical Properties	ASTM D3578-10
	Before Aging	After aging at 70±2 °C166±2 hrs	Before Aging	After aging at 70±2 °C166±2 hrs
- Tensile Strength	18Mpa min	14Mpa min	20.3~35.1Mpa	16.7~24.0Mpa
- Ultimate Elongation	650% min	500% min	961~1233%	748~1021%
- Stress at 500% Elongation	5.5Mpa max	--	4.6~5.4Mpa	--
Freedom from Holes	ASTM D5151-11		Passed Standard Acceptance CriteriaHoles at Inspection Level I, AQL 2.5
Powder Amount	ASTM D6124-11, ≤ 10mg/dm²		2.34 mg/dm², Meets ASTM D6124-11Results generated values below 10mg/dm² ofresidual powder
Protein Content	ASTM D5712-10, ≤200µg/dm² Aqueousextractable protein		Aqueous extractable protein: 72.1 mcg /dm²,Meets ASTM D5712-10 Results generated

values below 200µg/dm² of aqueous extractable

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Image /page/5/Picture/1 description: The image shows a logo with a circular design. The top half of the circle is light blue, while the bottom half is green. Within the green portion, there are several curved lines that resemble leaves or blades of grass. The overall design is simple and clean, with a focus on natural elements.

		protein content
Biocompatibility	Primary Skin Irritation in rabbits 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.

• The Powder-free Latex Patient Examination Gloves

Characteristics	Standard		Test Data
Dimension	ASTM D3578-10
Palm width	Size	(mm)		(mm)
	Small	80±10		80~84
	Medium	95±10		93~97
	Large	111±10		107~109
Overall Length	Size	(mm)		(mm)
	Small	220 min		240~246
	Medium	230 min		241~248
	Large	230 min		241~248
Finger Thickness	Size	(mm)		(mm)
	Small	0.08 min		0.09~0.12
	Medium	0.08 min		0.09~0.11
	Large	0.08 min		0.09~0.12
Palm Thickness	Size	(mm)		(mm)
	Small	0.08 min		0.10~0.12
	Medium	0.08 min		0.10~0.12
	Large	0.08 min		0.08~0.12
Physical Properties	ASTM D3578-10
	Before Aging	After aging at 70±2 °C166±2 hrs	Before Aging	After aging at 70±2 °C166±2 hrs
- Tensile Strength	18Mpa min	14Mpa min	18.4~32.3Mpa	18.7~24.5Mpa
- Ultimate Elongation	650% min	500% min	955~1148%	797~976%
- Stress at 500%Elongation	5.5Mpa max	--	4.8~5.4Mpa	--
Freedom from Holes	ASTM D5151-11		Passed Standard Acceptance CriteriaHoles at Inspection Level I, AQL 2.5
Powder residue	ASTM D6124-11, ≤2mg/glove		0.68 mg/glove, Meets ASTM D6124-11Results generated values below 2mg/glove ofresidual powder
Protein Content	ASTM D5712-10, ≤200µg/dm2 Aqueousextractable protein		Aqueous extractable protein: 70.8 mcg/dm2,Meets ASTM D5712-10, Results generatedvalues below 200µg/dm² of Aqueous extractableprotein content
Biocompatibility	Primary Skin Irritation in rabbits ISO		Under the condition of the test, not an irritant.

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Image /page/6/Picture/1 description: The image shows a logo with a circular design. The top half of the circle is blue, while the bottom half is green. Within the green portion, there are several curved lines that resemble blades of grass or leaves. The logo has a clean and modern look.

10993-10:2010-08-01
Dermal sensitization in the guinea pig ISO10993-10:2010-08-01	Under the condition of the test, not a sensitizer.

• The Powdered Nitrile Patient Examination Gloves

• The Powdered Nitrile Patient Examination Gloves
Characteristics	Standard			Test Data
Dimension	ASTM D6319-10
Palm width	Size	(mm)		(mm)
	Small	80±10		81~85
	Medium	95±10		95~99
	Large	110±10		110~114
Overall Length	Size	(mm)		(mm)
	Small	220 min		251~255
	Medium	230 min		250~262
	Large	230 min		259~264
Finger Thickness	Size	(mm)		(mm)
	Small	0.05 min		0.08
	Medium	0.05 min		0.08
	Large	0.05 min		0.08
Palm Thickness	Size	(mm)		(mm)
	Small	0.05 min		0.08
	Medium	0.05 min		0.08
	Large	0.05 min		0.08
Physical Properties	ASTM D6319-10
	Before Aging	After aging at 70±2 °C166±2 hrs	Before Aging	After aging at 70±2 °C166±2 hrs
- Tensile Strength	14Mpa min	14Mpa min	17.5~31.1Mpa	15.7~18.5Mpa
- Ultimate Elongation	500% min	400% min	761~948%	421~839%
Freedom from Holes	ASTM D5151-11		Passed Standard Acceptance Criteria
			Holes at Inspection Level G-1, AQL 2.5
Powder Amount	ASTM D6124-11, ≤ 10mg/dm²		1.86 mg/dm², Meets ASTM D6124-11Results generated values below 10mg/dm² ofresidual powder
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.

• The Powder-free Nitrile Patient Examination Gloves

Characteristics	Standard	Test Data
Dimension	ASTM D6319-10
Palm width	Size (mm)	(mm)

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Image /page/7/Picture/1 description: The image shows a logo with a circular shape. The top half of the circle is blue, and the bottom half is green. Inside the circle, there are several curved lines that resemble leaves or blades of grass. The lines are also green and are arranged in a fan-like pattern.

	Small	80±10		81~85
	Medium	95±10		94~99
	Large	110±10		110~114
Overall Length	Size	(mm)		(mm)
	Small	220 min		252~257
	Medium	230 min		255~260
	Large	230 min		257~263
Finger Thickness	Size	(mm)		(mm)
	Small	0.05 min		0.08
	Medium	0.05 min		0.08
	Large	0.05 min		0.08
Palm Thickness	Size	(mm)		(mm)
	Small	0.05 min		0.08
	Medium	0.05 min		0.08
	Large	0.05 min		0.08
Physical Properties	ASTM D6319-10
	Before Aging	After aging at 70±2 °C166±2 hrs	Before Aging	After aging at 70±2 °C166±2 hrs
- Tensile Strength	14Mpa min	14Mpa min	18.8~29.5Mpa	16.2~21.0Mpa
- Ultimate Elongation	500% min	400% min	745~945%	445~773%
Freedom from Holes	ASTM D5151-11		Passed Standard Acceptance CriteriaHoles at Inspection Level G-1, AQL 2.5
Powder residue	ASTM D6124-11, ≤2mg/glove		0.72 mg/glove, Meets ASTM D6124-11Results generated values below 2mg/glove ofresidual powder
Biocompatibility	Primary Skin Irritation in rabbits ISO10993-10:2010-08-01Dermal sensitization in the guinea pig ISO10993-10:2010-08-01		Under the condition of the test, not an irritant.Under the condition of the test, not a sensitizer.

5. Substantial Equivalent Based on Assessment of Non-Clinical Performance Data:

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

1. ASTM D3578-10, Standard Specification for Rubber Examination Gloves.

2. ASTM D5151-11, Standard Test Method for Detection of Holes in Medical Gloves.

3. ASTM D6124-11, Standard Test Method for Residual Powder on Medical Gloves.

4. ASTM D5712-10, Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rs

Products Using the Modified Lowry Method.

5. ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.

6. ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.

6. Substantial Equivalent Based on Assessment of Clinical Performance Data:

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Image /page/8/Picture/1 description: The image shows a logo with a circular design. The logo features a blue circle with a green, stylized image of a plant or bird inside. The green image has several curved lines that resemble leaves or feathers. The overall design is simple and modern.

Clinical data was not including in this submission.

7. Substantially Equivalent Comparison Conclusion

• For Powdered Latex Patient Examination Gloves

Parameters		New Device	Predicate Device
1	510(k) Number	K150612	K072145
2	Marketingclearance date	--	Feb 26th, 2008
3	Device Name	Annuy Powdered Latex Patient ExaminationGlove	Powdered Latex Patient Examination Glove
4	Manufacturer	Anhui Anyu Latex Products Co., Ltd	Zhanjiang Jiali Glove Products Co., LTD
5	Product Code	LYY	LYY
6	Regulation No.	21 CFR 880.6250	21 CFR 880.6250
7	Class	I	I
8	Intended use	A patient examination glove is a disposabledevice intended for medical purposes that isworn on the examiner's hand or finger toprevent contamination between patient andexaminer.	A patient examination glove is a disposabledevice intended for medical purposes that isworn on the examiner's hand or finger toprevent contamination between patient andexaminer.
9	Material	Natural Rubber Latex	Natural Rubber Latex
10	Design	Single useNon-sterilePowderedAmbidextrousCuffed	Single useNon-sterilePowderedAmbidextrousCuffed
11	Description	A device covering the hand and wrist area.Gloves have separate sheaths or openings foreach finger and the thumb.	A device covering the hand and wrist area.Gloves have separate sheaths or openingsfor each finger and the thumb.
12	Size	Provided in sizes small, medium and large	Provided in sizes small, medium and large
13	Specifications	Powdered Latex Examination Gloves MeetASTM D3578-10	Powdered Latex Examination Gloves MeetASTM D3578-05
14	Dimensions- Overall Length	Meets ASTM D3578-10Small: 220mm minMedium: 230mm minLarge: 230mm min	Meets ASTM D3578-05Small: 220mm minMedium: 230mm minLarge: 230mm min
15	Dimensions- Palm Width	Meets ASTM D3578-10Small: 80±10mmMedium: 95±10mmLarge: 111±10mm	Meets ASTM D3578-05Small: 80±10mmMedium: 95±10mmLarge: 111±10mm
16	Dimensions- Finger Thickness	Meets ASTM D3578-100.08mm min	Meets ASTM D3578-050.08mm min
	Dimensions- Palm Thickness	Meets ASTM D3578-100.08mm min	Meets ASTM D3578-050.08mm min
17	Physical Properties	Meets ASTM D3578-10	Meets ASTM D3578-05
		Before Aging:	Before Aging:
		- Tensile Strength: 18Mpa min	- Tensile Strength: 18Mpa min
		- Ultimate Elongation: 650% min	- Ultimate Elongation: 650% min
		- Stress at 500% Elongation: 5.5Mpa max	- Stress at 500% Elongation: 5.5Mpa max
		Meets ASTM D3578-10	Meets ASTM D3578-05
		After aging at 70±2 °C 166±2 hrs:	After aging at 70±2 °C 166±2 hrs:
		- Tensile Strength: 14Mpa min	- Tensile Strength: 14Mpa min
		- Ultimate Elongation: 500% min	- Ultimate Elongation: 500% min
18	Freedom from	Meets ASTM D3578-10 and ASTM D5151-11	Meets ASTM D3578-05 and ASTM
	Holes	Holes at Inspection Level I, AQL 2.5	D5151-06
19	Powder Amount	Meets ASTM D6124-11	Meets ASTM D6124-06
		Below 10mg/dm² of residual powder	Below 10mg/dm² of residual powder
20	Protein Content	Meets ASTM D5712-10,	Meets ASTM D5712-05
		Below 200µg/dm² of aqueous extractable	Below 200µg/dm² of aqueous extractable
		protein content	protein content
21	Absorbable donning	Cornstarch,	Cornstarch,
	or dusting powder	Powdered with absorbable dusting powder,	Powdered with absorbable dusting powder,
		U.S.P.	U.S.P.
22	Biocompatibility	Meets ISO 10993-10:2010;	Meets ISO 10993-10:2006;
		Skin Irritation: Under the condition of the	Skin Irritation: Under the condition of the
		test, not an irritant.	test, not an irritant.
		Skin Sensitization:Under the condition of the	Skin Sensitization:Under the condition of
		test, not a sensitizer.	the test, not a sensitizer.
23	Color	Creamy white, no colorant	Same
24	Labeling Features	Include the required labeling:	Include the required labeling:
		• Examination Gloves	• Examination Gloves
		• Non-sterile	• Single Use Only
		• Single Use Only	• Powdered
		• Powdered	• Size, Serial No., Manufacturing Date and
		• Ambidextrous	Quantity
		• Natural rubber latex	• Natural rubber latex
		• Device color: Creamy white	• Protein Label Claims
		• Allergy warning	• Allergy warning
		• Contents, Size, Lot No. and Manufacturing	• Manufacturer Name and Address
		Date
		• Storage conditions
		• Manufacturer Name and Address

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Image /page/9/Picture/1 description: The image shows a logo with a circular design. The top half of the circle is blue, while the bottom half is green. Within the green portion, there are several curved lines that resemble blades of grass or stylized leaves. The overall design is simple and modern, suggesting a connection to nature or the environment.

• For Powder-free Latex Patient Examination Gloves

	Parameters	New Device	Predicate Device
1	510(k) Number	K150612	K072145
2	Marketingclearance date	--	Feb 26th, 2008
3	Device Name	Annuy Powder free Latex Patient Examination Glove	Powder free Latex Patient Examination Glove
4	Manufacturer	Anhui Anyu Latex Products Co., Ltd	Zhanjiang Jiali Glove Products Co., LTD
5	Product Code	LYY	LYY
6	Regulation No.	21 CFR 880.6250	21 CFR 880.6250
7	Class	I	I
8	Intended use	A patient examination glove is a disposabledevice intended for medical purposes that isworn on the examiner's hand or finger toprevent contamination between patient andexaminer.	A patient examination glove is a disposabledevice intended for medical purposes that isworn on the examiner's hand or finger toprevent contamination between patient andexaminer.
9	Material	Natural Rubber Latex	Natural Rubber Latex
10	Design	Single useNon-sterilePowder freeAmbidextrousCuffed	Single useNon-sterilePowder freeAmbidextrousCuffed
11	Description	A device covering the hand and wrist area.Gloves have separate sheaths or openings foreach finger and the thumb.	A device covering the hand and wrist area.Gloves have separate sheaths or openingsfor each finger and the thumb.
12	Size	Provided in sizes small, medium and large	Provided in sizes small, medium and large
13	Specifications	Powdered Latex Examination Gloves MeetASTM D3578-10	Powdered Latex Examination Gloves MeetASTM D3578-05
14	Dimensions- Overall Length	Meets ASTM D3578-10Small: 220mm minMedium: 230mm minLarge: 230mm min	Meets ASTM D3578-05Small: 220mm minMedium: 230mm minLarge: 230mm min
15	Dimensions- Palm Width	Meets ASTM D3578-10Small: 80±10mmMedium: 95±10mmLarge: 111±10mm	Meets ASTM D3578-05Small: 80±10mmMedium: 95±10mmLarge: 111±10mm
16	Dimensions- Finger Thickness	Meets ASTM D3578-100.08mm min	Meets ASTM D3578-050.08mm min
	Dimensions- Palm Thickness	Meets ASTM D3578-100.08mm min	Meets ASTM D3578-050.08mm min
17	Physical Properties	Meets ASTM D3578-10Before Aging:- Tensile Strength: 18Mpa min- Ultimate Elongation: 650% min- Stress at 500% Elongation: 5.5Mpa maxMeets ASTM D3578-10After aging at 70±2 °C 166±2 hrs:- Tensile Strength: 14Mpa min- Ultimate Elongation: 500% min	Meets ASTM D3578-05Before Aging:- Tensile Strength: 18Mpa min- Ultimate Elongation: 650% min- Stress at 500% Elongation: 5.5Mpa maxMeets ASTM D3578-05After aging at 70±2 °C 166±2 hrs:- Tensile Strength: 14Mpa min- Ultimate Elongation: 500% min
18	Freedom fromHoles	Meets ASTM D3578-10 and ASTM D5151-11Holes at Inspection Level I, AQL 2.5	Meets ASTM D3578-05 and ASTMD5151-06
ANHUI YU LATEX PRODUCTS CO., LTDEAST QINJI ROAD & NORTH XINGHUA ROAD, BENGBU, ANHUI, 233010 CHINA
19	Powder residue	Meets ASTM D6124-11Below 2mg/glove of residual powder	Meets ASTM D6124-06Below 2mg/glove of residual powder
20	Protein Content	Meets ASTM D5712-10,Below 200µg/dm² of aqueous soluble proteincontent	Meets ASTM D5712-05,Below 200µg/dm² of aqueous solubleprotein content
21	Polymer Coating	It is coated with a polyurethane based coatingon the inner side to facilitate donning.Polymer name: polyurethane & polyacrylicacid	It is coated with a polyurethane basedcoating on the inner side to facilitatedonning.Polymer name: polyurethane & polyacrylicacid
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 10993-10:2006;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:• Examination Gloves• Non-sterile• Disposable• Powder-free• Ambidextrous• Natural rubber latex• Device color: Creamy white• Allergy warning• Contents, Size, Lot No. and ManufacturingDate• Storage conditions	Include the required labeling:• Examination Gloves• Single Use Only• Powder-free• Size, Serial No., Manufacturing Date andQuantity• Natural rubber latex• Protein Label Claims• Allergy warning• Manufacturer Name and Address

{10}------------------------------------------------

{11}------------------------------------------------

ANHUI ANYU LATEX PRODUCTS CO., LTD EA

• For Powdered Nitrile Patient Examination Gloves

• Manufacturer Name and Address

	Parameters	New Device	Predicate Device
1	510(k) Number	K150612	K072145
2	Marketing clearance date	--	Feb 26th, 2008
3	Device Name	Annuy Powdered Nitrile Patient Examination Glove	Powdered Nitrile Patient Examination Glove
4	Manufacturer	Anhui Anyu Latex Products Co., Ltd	Zhanjiang Jiali Glove Products Co., LTD
5	Product Code	LZA	LZA
6	Regulation No.	21 CFR 880.6250	21 CFR 880.6250
7	Class	I	I
8	Intended use	A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and	A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and
		examiner.	examiner.
9	Material	Nitrile Butadiene Rubber Latex	Nitrile Butadiene Rubber Latex
10	Design	Single use	Single use
		Non-sterile	Non-sterile
		Powdered	Powdered
		Ambidextrous	Ambidextrous
		Cuffed	Cuffed
11	Description	A device covering the hand and wrist area.	A device covering the hand and wrist area.
		Gloves have separate sheaths or openings for	Gloves have separate sheaths or openings
		each finger and the thumb.	for each finger and the thumb.
12	Size	Provided in sizes small, medium and large	Provided in sizes small, medium and large
13	Specifications	Powdered Nitrile Examination Gloves Meet	Powdered Nitrile Examination Gloves Meet
		ASTM D6319-10	ASTM D6319-05
14	Dimensions	Meets ASTM D6319-10	Meets ASTM D6319-05
	- Overall Length	Small: 220mm min	Small: 220mm min
		Medium: 230mm min	Medium: 230mm min
		Large: 230mm min	Large: 230mm min
15	Dimensions	Small: 80±10mm	Small: 80±10mm
	- Palm Width	Medium: 95±10mm	Medium: 95±10mm
		Large: 110±10mm	Large: 110±10mm
		Meets ASTM D6319-10	Meets ASTM D6319-05
16	Dimensions	Meets ASTM D6319-10	Meets ASTM D6319-05
	- Finger Thickness	0.05mm min	0.05mm min
	Dimensions	Meets ASTM D6319-10	Meets ASTM D6319-05
	- Palm Thickness	0.05mm min	0.05mm min
17	Physical Properties	Meets ASTM D6319-10	Meets ASTM D6319-05
		Before Aging:	Before Aging:
		- Tensile Strength: 14Mpa min	- Tensile Strength: 14Mpa min
		- Ultimate Elongation:500% min	- Ultimate Elongation:500% min
		Meets ASTM D6319-10	Meets ASTM D6319-05
		After aging at 70±2 °C 166±2 hrs:	After aging at 70±2 °C 166±2 hrs:
		- Tensile Strength: 14Mpa min	- Tensile Strength: 14Mpa min
		- Ultimate Elongation: 400% min	- Ultimate Elongation: 400% min
18	Freedom from	Meets ASTM D6319-10 and ASTM	Meets ASTM D6319-05 and ASTM
	Holes	D5151-11;	D5151-06
		Holes at Inspection Level G-1, AQL 2.5
19	Powder Amount	Meets ASTM D6124-11,	Meets ASTM D6124-06
		Below 10mg/dm²	Below 10mg/dm² of residual powder
20	Absorbable donning	Cornstarch,	Cornstarch,
	or dusting powder	Powdered with absorbable dusting powder,	Powdered with absorbable dusting powder,
		U.S.P.	U.S.P.
21	Biocompatibility	Meets ISO 10993-10:2010;	Meets ISO 10993-10:2006;
		Skin Irritation: Under the condition of the	Skin Irritation: Under the condition of the
		test, not an irritant.	test, not an irritant.
		Skin Sensitization:Under the condition of the	Skin Sensitization:Under the condition of
		test, not a sensitizer.	the test, not a sensitizer.
22	Color	BlueChemical characterization:Copper Phthalocyanine β modification	BlueChemical characterization:Copper Phthalocyanine β modification
23	Labeling Features	Include the required labeling:• Nitrile Examination Gloves• Non-sterile• Disposable• Powdered• Ambidextrous• Device color: Blue• Contents, Size, Lot No. and Manufacturing Date• Storage conditions• Manufacturer Name and Address	Include the required labeling:• Nitrile Examination Gloves• Single Use Only• Powdered• Size, Serial No., Manufacturing Date and Quantity• Manufacturer Name and Address

{12}------------------------------------------------

{13}------------------------------------------------

Image /page/13/Picture/1 description: The image shows a logo with a circular shape. The left side of the circle is blue, while the right side is green. Inside the circle, there are curved lines that resemble a plant or a wave. The logo has a clean and modern design.

• For Powder-free Nitrile Patient Examination Gloves

	Parameters	New Device	Predicate Device
1	510(k) Number	K150612	K072145
2	Marketing clearance date	--	Feb 26th, 2008
3	Device Name	Annuy Powder-free Nitrile Patient Examination Glove	Powder-free Nitrile Patient Examination Glove
4	Manufacturer	Anhui Anyu Latex Products Co., Ltd	Zhanjiang Jiali Glove Products Co., LTD
5	Product Code	LZA	LZA
6	Regulation No.	21 CFR 880.6250	21 CFR 880.6250
7	Class	I	I
8	Intended use	A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.	A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
9	Material	Nitrile Butadiene Rubber Latex	Nitrile Butadiene Rubber Latex
10	Design	Single useNon-sterilePowder-freeAmbidextrousCuffed	Single useNon-sterilePowder-freeAmbidextrousCuffed
11	Description	A device covering the hand and wrist area. Gloves have separate sheaths or openings for each finger and the thumb.	A device covering the hand and wrist area. Gloves have separate sheaths or openings for each finger and the thumb.
12	Size	Provided in sizes small, medium and large	Provided in sizes small, medium and large
13	Specifications	Powder-free Nitrile Examination Gloves Meet ASTM D6319-10	Powder-free Nitrile Examination Gloves Meet ASTM D6319-05
14	Dimensions- Overall Length	Meets ASTM D6319-10Small: 220mm minMedium: 230mm minLarge: 230mm min	Meets ASTM D6319-05Small: 220mm minMedium: 230mm minLarge: 230mm min
15	Dimensions- Palm Width	Meets ASTM D6319-10Small: 80±10mmMedium: 95±10mmLarge: 110±10mm	Meets ASTM D6319-05Small: 80±10mmMedium: 95±10mmLarge: 110±10mm
16	Dimensions- Finger Thickness	Meets ASTM D6319-100.05mm min	Meets ASTM D6319-050.05mm min
	Dimensions- Palm Thickness	Meets ASTM D6319-100.05mm min	Meets ASTM D6319-050.05mm min
17	Physical Properties	Meets ASTM D6319-10Before Aging:- Tensile Strength: 14Mpa min- Ultimate Elongation:500% minMeets ASTM D6319-10After aging at 70±2 °C 166±2 hrs:- Tensile Strength: 14Mpa min- Ultimate Elongation: 400% min	Meets ASTM D6319-05Before Aging:- Tensile Strength: 14Mpa min- Ultimate Elongation:500% minMeets ASTM D6319-05After aging at 70±2 °C 166±2 hrs:- Tensile Strength: 14Mpa min- Ultimate Elongation: 400% min
18	Freedom fromHoles	Meets ASTM D6319-10 and ASTMD5151-11;Holes at Inspection Level G-1, AQL 2.5	Meets ASTM D6319-05 and ASTMD5151-06
19	Powder residue	Meets ASTM D6124-11Below 2mg/glove of residual powder	Meets ASTM D6124-06Below 2mg/glove of residual powder
20	Polymer Coating	It is coated with a polyurethane based coatingon the inner side to facilitate donning.Polymer name: polyurethane & polyacrylicacid	It is coated with a polyurethane basedcoating on the inner side to facilitatedonning.Polymer name: polyurethane & polyacrylicacid
21	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 10993-10:2006;Skin Irritation: Under the condition of thetest, not an irritant.Skin Sensitization: Under the condition ofthe test, not a sensitizer.
22	Color	BlueChemical characterization:Copper Phthalocyanine β modification	BlueChemical characterization:Copper Phthalocyanine β modification
23	Labeling Features	Include the required labeling:• Nitrile Examination Gloves• Non-sterile• Disposable• Powder-free• Ambidextrous	Include the required labeling:• Nitrile Examination Gloves• Single Use Only• Powder-free• Size, Serial No., Manufacturing Date andQuantity

{14}------------------------------------------------

Image /page/14/Picture/1 description: The image shows a logo with a circular design. The top half of the circle is blue, while the bottom half is green. Within the green portion, there are several curved lines that resemble blades of grass or leaves. The overall design is simple and clean, with a focus on natural elements.

{15}------------------------------------------------

Image /page/15/Picture/1 description: The image shows a logo with a circular shape. The top half of the circle is blue, while the bottom half is green. Within the green portion, there are several white lines that resemble blades of grass or stylized leaves. The overall design is simple and clean, suggesting a focus on nature or the environment.

	Contents, Size, Lot No. and ManufacturingDate Storage conditions Manufacturer Name and Address
--	----------------------------------------------------------------------------------------------------

Discussion: Based on the above comparison, the Annuy Latex Examination Gloves (Powdered and Powder-Free), Annuy Nitrile Examination Gloves (Powdered and Powder-Free) and the predicate device have same technology characteristics such as material, design, intended use, specification and performance features.

Both the subject device and predicate device meet the technology characteristics of ASTM D3578, ASTM D6319 and ISO10993-10 standards. From the tests, results generated values that,

Annuy Powdered Latex Examination Gloves contain no more than 10mg/dm² powder and no more than 200µg/dm² extractable protein.

Annuy Powder-free Latex Examination Gloves contain no more than 2mg/glove of residual powder and no more than 200ug/dm2 extractable protein.

Annuy Powdered Nitrile Examination Gloves contain no more than 10mg/dm² powder.

Annuy Powder-free Nitrile Examination Gloves contain no more than 2mg/glove of residual powder.

Conclusion: The Annuy Latex Examination Gloves (Powder-Free) and Nitrile Examination Gloves

(Powdered and Powder-Free) manufactured by Anhui Anyu Latex Products Co., Ltd are substantially equivalent to the predicate device (K072145).

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.