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 sterility of a latex examination glove, with no mention of AI or ML.

Therapeutic

No.
The device is intended to prevent contamination between patient and examiner, not to treat a disease or condition.

Diagnostic

No

The device is a patient examination glove, which is a barrier device used to prevent contamination, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device is a physical glove made of latex, not software. The description focuses on material properties and physical performance tests.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is clearly stated as being worn on the examiner's hand or finger to prevent contamination between patient and examiner. This is a barrier device for physical protection.
Device Description: The description focuses on the physical properties and standards met by the glove (latex compound, sterile, powder-free, ambidextrous, meeting ASTM standards).
No mention of in vitro testing: There is no indication that this device is used to examine specimens in vitro (outside of the body) to provide information about a patient's health. IVDs are typically used for tests on blood, urine, tissue, etc.
Performance Studies: The performance studies listed are related to the physical integrity and safety of the glove as a barrier (freedom from holes, dimensions, physical properties, biocompatibility, sterility). These are not studies related to diagnostic accuracy or performance in analyzing biological samples.

This device is a medical device, specifically a patient examination glove, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Sterile Latex Patient Examination gloves, Powder Free, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.

Product codes (comma separated list FDA assigned to the subject device)

LYY

Device Description

The subject device is a patient examination glove made of latex compound. It is sterile, Powder Free. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D3578-05: Standard specification for Rubber Examination Gloves. The subject device is substantially equivalent to legally marketed Latex Examination Powder Free gloves identified as Product code LYY. The device is for over-the counter single use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hand or Finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Examiners / Not found

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)

There is no difference in technological characteristics compared to the predicate device. Gloves are made from Latex compound, which is Sterile and Powder Free. The gloves have the same technological characteristics compared to ASTM or equivalent standards as given below,

Characteristics	Standards	Performance of Latex patient examination gloves, Powder Free
Freedom from Holes	ASTM D3578-05/ ASTM D5151-06	Meets
Dimensions	ASTM D3578-05	Meets
Physical Properties	ASTM D3578-05/ ASTM D412-06	Meets
Powder-free residue	ASTM D3578-05/ ASTM D6124-06	Meets
Residual Protein	ASTM D3578-05/ ASTM D5712-15	Meets
Bio-compatibility	Primary skin irritation ISO 10993-10	Non-irritant
	Skin Sensitization ISO 10993-10	Non-sensitizer
Expiration dating/Shelf life	ASTM D7160-05	Three years
Sterilization	ISO 11135-2014(E) Sterilization of healthcare products - Ethylene Oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices	Meets
Sterility	ISO 11737 -2 Sterilization of Medical devices- Microbiological methods Part 2: Test of sterility performed in the definition, validation and maintenance of sterilization process	Sterile

Performance data of gloves based on ASTM D3578-05and FDA 1000ml water leak test

Characteristics	Test	Test standard	Sampling plan / Inspection level / AQL	Sterile, Powder Free, Latex Patient Examination Gloves- Sancare / Glovtek	Result
Freedom from Pin holes	FDA 1000 ml water leak test	ASTM D5151 -06 (Re-approved 2011)	ISO 2859-1 / G1/AQL 2.5	PASS	PASS
Dimensions	Length	ASTM D3578-05	ISO 2859-1 / S2/AQL 4.0	> 230 mm	PASS
	Width	ASTM D3578-05	ISO 2859-1 / S2/AQL 4.0	70±10 mm to 120±10 mm (sizes XS to XL)	PASS
	Thickness	ASTM D3578-05	ISO 2859-1 / S2/AQL 4.0	> 0.08 mm (Cuff, palm& finger)	PASS
Physical properties	Before aging	ASTM D3578-05and ASTM D412-06	ISO 2859-1 / S2/AQL 4.0	Tensile strength : > 18 Mpa	PASS
				Ultimate Elongation : >650%	PASS
				Stress at 500% elongation : 5.5 Mpa max	PASS
	After Accelerated aging	ASTM D3578-05and ASTM D573-04	ISO 2859-1 / S2/AQL 4.0	Tensile strength : > 14 Mpa	PASS
				Ultimate Elongation : > 500%	PASS
Powder-free residue	Powder-free residue	ASTM D3578-05and ASTM D6124-06	N=5	Less than 2 mg per glove	PASS
Residual Protein	Residual Protein	ASTM D3578-05 and ASTM D 5712 – 15	N=3	Residual Protein : Less than 50µg/dm²	PASS
Biocompatibility	Primary skin irritation	ISO 10993 -10		Under the conditions of the study the device is not an irritant	PASS
	Skin Sensitization	ISO 10993 -10		Under the conditions of the study the device is not a sensitizer	PASS
Sterility	Sterility	ISO-11737-2		Sterile	PASS

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.

K052728

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

§ 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.

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA part includes the acronym "FDA" in blue, followed by "U.S. FOOD & DRUG" and "ADMINISTRATION" in a smaller font size.

January 26, 2018

Sanrea Healthcare Products Pvt Ltd Jose Paul M Manager QA & RA Plot#P-56, Pearl Road, Kinfra IIT Park, Kanjikode, Palakkad, 678 621, Kerala, IN

Re: K171367

Trade/Device Name: SANCARE STERILE LATEX EXAMINATION GLOVES Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYY Dated: December 26, 2017 Received: December 28, 2017

Dear Jose Paul M:

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.

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 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);

1

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting 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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Indications for Use

510(k) Number (if known) K171367

Device Name SANCARE STERILE LATEX EXAMINATION GLOVES

Indications for Use (Describe)

The Sterile Latex Patient Examination gloves, Powder Free, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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K171367

1.0 SUBMITTER

1.1 Company Name	:	SANREA HEALTHCARE PRODUCTS PVT LTD
1.2 Address	:	Plot#P-56, Pearl Road, Kinfra Integrated Industrial &
Textile Park, Kanjikode, Palakkad
Kerala, India– 678 621
1.3 Telephone	:	+ 91-491-2970145
1.4 Email	:	josepaul@primusgloves.com, sanreaqa@gmail.com,
qa@sanrea.com
1.5 Contact Person	:	Mr. JOSE PAUL M
MANAGER QA & RA

2.0 OFFICIAL CORRESPONDENT

2.1 Company Name	:	SANREA HEALTHCARE PRODUCTS PVT LTD
2.2 Address	:	Plot#P-56, Pearl Road, Kinfra Integrated Industrial &
Textile Park, Kanjikode, Palakkad
Kerala, India– 678 621
2.3 Telephone	:	+ 91-491 -2970145
2.4 Email	:	josepaul@primusgloves.com, sanreaqa@gmail.com,
qa@sanrea.com
2.5 Contact Person	:	Mr. JOSE PAUL M
MANAGER QA & RA

3.0 PREPARATION DATE :

4

4.0 NAME OF THE DEVICE

| 4.1 Device Name | : | STERILE LATEX PATIENT EXAMINATION
GLOVES, POWDER FREE |
|--------------------|---|---------------------------------------------------------------------------------------------------------|
| 4.2 Trade Name | : | SANCARE STERILE LATEX EXAMINATION GLOVES (also
marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) |
| 4.3 Common Name | : | PATIENT EXAMINATION GLOVES |
| 4.4 Classification | : | PATIENT EXAMINATION GLOVES |
| 4.5 Class | : | CLASS I |
| 4.6 Product Code | : | LYY |

IDENTIFICATION OF LEGALLY MARKETED PREDICATE DEVICE 5.0

5.1 Device Name	:	Powder free Latex Sterile Patient Examination Gloves
5.2 510(k) Number	:	K052728
5.3 Company	:	M/S. KANAM LATEX INDUSTRIES PVT. LTD.
Ooppoottil Buildings, K.K. Road,
Kottayam, Kerala, 686001
5.4 Device Description	:	Powder free Latex Sterile Patient Examination Gloves
5.5 Classification	:	PATIENT EXAMINATION GLOVES
5.6 Class	:	CLASS I
5.7 Product Code	:	LYY
5.8 Classification Panel	:	General Hospital

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6.0 DESCRIPTION OF THE DEVICE

The subject device is a patient examination glove made of latex compound. It is sterile, Powder Free. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D3578-05: Standard specification for Rubber Examination Gloves. The subject device is substantially equivalent to legally marketed Latex Examination Powder Free gloves identified as Product code LYY. The device is for over-the counter single use.

7.0 INDICATIONS FOR USE

The Sterile Latex Patient Examination gloves, Powder Free, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.

8.0 SUMMARY OF PERFORMANCE DATA

There is no difference in technological characteristics compared to the predicate device. Gloves are made from Latex compound, which is Sterile and Powder Free. The gloves have the same technological characteristics compared to ASTM or equivalent standards as given below,

| Characteristics | Standards | Performance of Latex
patient examination
gloves, Powder Free |
|---------------------|-----------------------------------------|--------------------------------------------------------------------|
| Freedom from Holes | ASTM D3578-05/ ASTM D5151-06 | Meets |
| Dimensions | ASTM D3578-05 | Meets |
| Physical Properties | ASTM D3578-05/ ASTM D412-06 | Meets |
| Powder-free residue | ASTM D3578-05/ ASTM D6124-06 | Meets |
| Residual Protein | ASTM D3578-05/ ASTM D5712-15 | Meets |
| Bio-compatibility | Primary skin irritation
ISO 10993-10 | Non-irritant |
| | Skin Sensitization | Non-sensitizer |

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	ISO 10993-10
Expiration dating/Shelf life	ASTM D7160-05	Three years
Sterilization	ISO 11135-2014(E)
Sterilization of healthcare products -
Ethylene Oxide - Requirements for
the development, validation and
routine control of a sterilization
process for medical devices	Meets
Sterility	ISO 11737 -2
Sterilization of Medical devices-
Microbiological methods Part 2:
Test of sterility performed in the
definition, validation and
maintenance of sterilization process	Sterile

Performance data of gloves based on ASTM D3578-05and FDA 1000ml water leak test

Г

ASTM D3578-05and FDA 1000 ml water leak test
Characteristics	Test	Test standard	Sampling
plan /
Inspection
level / AQL	Sterile, Powder Free,
Latex Patient
Examination Gloves-
Sancare / Glovtek	Result
Freedom from
Pin holes	FDA 1000
ml water
leak test	ASTM D5151 -06
(Re-approved 2011)	ISO 2859-1 /
G1/AQL 2.5	PASS	PASS
Dimensions	Length	ASTM D3578-05	ISO 2859-1 /
S2/AQL 4.0	> 230 mm	PASS
	Width	ASTM D3578-05	ISO 2859-1 /
S2/AQL 4.0	70±10 mm to 120±10
mm
(sizes XS to XL)	PASS
		ASTM D3578-05	ISO 2859-1 /	> 0.08 mm	PASS

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	Thickness		S2/AQL 4.0	(Cuff, palm& finger)
Physical
properties	Before
aging	ASTM D3578-05and
ASTM D412-06	ISO 2859-1 /
S2/AQL 4.0	Tensile strength :

18 Mpa | PASS |
| | | | | Ultimate Elongation :
650% | PASS |
| | | | | Stress at 500%
elongation :
5.5 Mpa max | PASS |
| | | | | | |
| | After
Accelerated
aging | ASTM D3578-05and
ASTM D573-04 | ISO 2859-1 /
S2/AQL 4.0 | Tensile strength :
14 Mpa | PASS |
| | | | | Ultimate Elongation :
500% | PASS |
| | | | | | |
| | | | | | |
| | | | | | |
| Powder-free
residue | Powder-free
residue | ASTM D3578-05and
ASTM D6124-06 | N=5 | Less than 2 mg per
glove | PASS |
| Residual Protein | Residual
Protein | ASTM D3578-05 and
ASTM D 5712 – 15 | N=3 | Residual Protein : Less
than 50µg/dm² | PASS |
| Biocompatibility | Primary skin
irritation | ISO 10993 -10 | | Under the conditions of the study the
device is not an irritant | PASS |
| | | | | | |
| | Skin
Sensitization | ISO 10993 -10 | | Under the conditions of the study the
device is not a sensitizer | PASS |
| | | | | | |
| Sterility | Sterility | ISO-11737-2 | | Sterile | PASS |
| | | | | | |

9.0 Predicate Comparison Chart

Characteristics	PREDICATE – 510(K) :	SUBJECT DEVICE :	Comparison
	K052728
Manufacturer	M/S. KANAM LATEX
INDUSTRIES PVT. LTD.
Ooppoottil Buildings,
K.K. Road,
Kottayam, Kerala, 686001	SANREA HEALTHCARE
PRODUCTS PVT LTD. Plot #
P-56, Pearl Road, Kinfra
Integrated Industrial & Textile
Park, Kanjikode, Palakkad,
Kerala, India – 678 621	-
Product Name	Powder free Latex Sterile
Patient Examination Gloves	Sterile Latex Patient
Examination Gloves, Powder
Free	Similar

Intended Use	Intended for medical purpose	Intended for medical purpose	Similar
	that is worn on the Examiners	that is worn on the
	hand or finger to prevent	Examiners hand or finger to
	contamination between	prevent contamination
	patient and examiner	between patient and
		examiner
Indication for	A Powder Free Patient	The Sterile Latex Patient	Similar
use	Examination Glove is a	Examination gloves, Powder
	Disposable Device made of	Free is a disposable device
	Natural Rubber Latex and is	intended for medical
	intended to be worn on the	purposes that is worn on the
	hands, for medical purposes	examiners hand or finger to
	to provide a barrier against	prevent contamination
	potentially infectious	between patient and
	materials and other	examiner
	contaminants.
Description	Sterile Powder Free, Patient	Sterile Powder Free, Patient	Similar
	Examination gloves made of	Examination gloves made of
	natural rubber latex. The	natural rubber latex. The
	gloves are provided in Sizes	gloves are provided in Sizes
	Extra Small, Small, Medium,	Extra Small, Small, Medium,
	Large and Extra Large	Large and Extra Large
Presentation	Sterile gloves are provided in	Sterile gloves are provided in	Identical
	pouches	pouches
Material	Natural Rubber Latex	Natural Rubber Latex	Identical
Product code	LYY	LYY	Identical
Non-sterile or	Sterile	Sterile	Identical
sterile
Single Use	Yes	Yes	Identical
Ambidextrous	Yes	Yes	Identical
	Meets ASTM D3578	Meets ASTMD3578 -	Identical
		Overall length min 230 mm,
Dimensions		width varies from 70 mm for
		XS size to 120 mm for XL
		size, thickness in cuff, finger
		and palm has a minimum
		0.08 mm
	Meets ASTM D 3578and	Meets ASTM D 3578 and	Identical
	ASTM D412, D573	ASTM D412, D573 -
Tensile Strength		Tensile strength 18 Mpa min
		for before aging and 14 Mpa
		min for after aging
		Aging done at 70 ±2 deg C
		for 166±2 hrs or 100±2deg C
		for 22±0.3 hrs
	Meets ASTM D 3578	Meets ASTM D 3578	Identical
		Ultimate elongation 650 %
Ultimate		min for before aging and 500
Elongation		% min for after aging. Aging
		done at 70 ±2 deg C for
		166±2 hrs or 100±2 deg C
		for 22±0.3 hrs
Stress at 500%	Meets ASTM D 3578	Meets ASTM D3578 -	Identical
Elongation		Stress at 500% Elongation
		for before aging is 5.5Mpa
(max)
Freedom from	Meets ASTM D 5151 and	Meets ASTM D 5151 and	Identical
pinholes	ASTM D3578	ASTM D3578
		Meets ASTM D 6124	Identical
Residual Powder	Meets ASTM D 6124	Less than 2 mg per glove
Residual Protein	Meets ASTM D 5712	Meets ASTM D 5712 –
Less than 50µg/dm²	Identical
Biocompatibility
Tests	Non-irritant –
Primary Skin Irritation In
Rabbits	Under the conditions of the
study the device is not an
irritant	Identical
ISO 10993-10	Non-sensitizer –
Skin Sensitization in Guinea
pigs	Under the conditions of the
study the device is not a
sensitizer	Identical
Sterility	Ethylene Oxide sterilized	Ethylene Oxide sterilized	Identical
Labeling	* Powder Free

Latex patient exam glove
Sterile
Single use only
Ambidextrous
Manufactured for
Lot No
Intended use
Quantity
Country of origin | *Powder Free
*Latex Patient exam glove
*Sterile
*Single use only
*Ambidextrous
*Manufactured for
*Lot No
*Intended use
*Quantity
*Country of origin | Identical |

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9

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10.0 CONCLUSION

Based on the intended use, physical properties and technological characteristics, the subject device is as safe, as effective and performs as well as the legally marketed predicate device.