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 regulatory standards for examination gloves, with no mention of AI or ML.

Therapeutic

No
The device is a patient examination glove used to prevent contamination, not to treat a disease or condition.

Diagnostic

No

The device is a glove, which is used for protection and to prevent contamination, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device is a physical examination glove made of vinyl, not software. The description clearly details a tangible product and its material properties.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a barrier function, not a diagnostic test performed in vitro (outside the body).
Device Description: The device is a glove made of vinyl. This is a physical barrier, not a reagent or instrument used to analyze biological samples.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening

The device is clearly described as a medical device intended for examination purposes, focusing on barrier protection and meeting performance standards for gloves.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The POWDER FREE patient examination gloves 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)

LYZ

Device Description

The subject device is a vinyl examination glove made of synthetic poly vinyl chloride compound. It is sterile, POWDER FREE. The device is ambidextrous. The device meets ASTM D 5250-06: Standard specification for poly vinyl chloride gloves for medical application. 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

Examiner / 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)

Performance data based on ASTM D 5250-06 and FDA 1000ml water leak test, and ISO standards for biocompatibility and sterility. The device "Meets" or "PASS" criteria for:

Freedom from Holes: ASTM D 5250-06/ ASTM D5151-06
Dimensions: ASTM D 5250-06
Physical Properties: ASTM D 5250-06 / ASTM D412-06 (Before aging and After Accelerated aging)
POWDER FREE residue: ASTM D 5250-06 and ASTM D6124-06 (Less than 2 mg per glove)
Bio-compatibility (Primary skin irritation, Skin/Dermal Sensitization): ISO 10993-10 (Non-irritant, Non-sensitizer)
Expiration dating/Shelf life: ASTM D7160-05 (Three years)
Sterility: ISO 11737-02

Specific results include:

Freedom from Pin holes: FDA 1000 ml water leak test, ASTM D5151-06 (reap 2011), ISO 2859-1 / G1/AQL 2.5 - PASS
Length: ASTM D 5250-06, ISO 2859-1 / S2/AQL 4.0 - > 230 mm, PASS
Width: ASTM D 5250-06, ISO 2859-1 / S2/AQL 4.0 - 85±5 mm to 115±5 mm (sizes S to XL), PASS
Thickness: ASTM D 5250-06, ISO 2859-1 / S2/AQL 4.0 - > 0.05 in finger & 0.08 in palm, PASS
Tensile strength (Before aging and After Accelerated aging): ASTM D 5250-06 and ASTM D412-06, ISO 2859-1 / S2/AQL 4.0 - > 11 Mpa, PASS
Ultimate Elongation (Before aging and After Accelerated aging): ASTM D 5250-06 and ASTM D412-06, ISO 2859-1 / S2/AQL 4.0 - > 300 %, PASS
POWDER FREE residue: ASTM D 5250-06 and ASTM D6124-06, N=5 - Less than 2 mg per glove, PASS
Primary skin irritation: ISO 10993-10 - Under the conditions of the study the device is not an irritant, PASS
Skin/Dermal Sensitization: ISO 10993-10 - Under the conditions of the study the device is not a sensitizer, PASS
Sterility: ISO 11737-02 - 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.

K053523

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

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo.

October 23, 2017

Primus Gloves, Pvt. Limited Jose Paul M Manager QA & RA Plot No 14-A, Cochin Special Economic Zone, Kakkanad Cochin, 682037 INDIA

Re: K170612

Trade/Device Name: Sterile Vinyl Examination Gloves, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: September 25, 2017 Received: September 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

1

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 (DICE) 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) 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,

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

2

Indications for Use

510(k) Number (if known) K170612

Device Name STERILE VINYL EXAMINATION GLOVES, POWDER FREE

Indications for Use (Describe)

The POWDER FREE patient examination gloves 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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3

SUBMITTER 1.0

1.1	Company Name	:	PRIMUS GLOVES PRIVATE LIMITED
1.2	Address	:	Plot No: 14-A, Cochin Special Economic Zone
Kakkanad, Cochin, Kerala, India - 682037
1.3	Telephone	:	+ 91 484 2413063
1.4	Fax	:	+91 484 2413089
1.5	Email	:	josepaul@primusgloves.com
1.6	Contact Person	:	Mr. JOSE PAUL M
MANAGER – QA & RA

OFFICIAL CORRESPONDENT 2.0

2.1 Company Name	PRIMUS GLOVES PRIVATE LIMITED
2.2 Address	Plot No: 14-A, Cochin Special Economic Zone, Kakkanad, Cochin, Kerala, India - 682037
2.3 Telephone	+ 91 484 2413063
2.4 Fax	+91 484 2413089
2.5 Email	josepaul@primusgloves.com
2.6 Contact Person	Mr. JOSE PAUL M
	MANAGER — QA & RA
3.0 Preparation date	13th OCTOBER, 2017
4.0 Name of the device
4.1 Device Name	STERILE VINYL EXAMINATION GLOVES, POWDER FREE,
4.2 Trade Name	PRIMUS VINYL EXAMINATION GLOVES PF
4.3 Common Name	PATIENT EXAMINATION GLOVES
4.4 Classification	PATIENT EXAMINATION GLOVES
4.5 Class	CLASS I
4.6 Product code	LYZ
4.7 510(K)Number	K 170612

4

K170612

5.0 Identification of the legally marketed predicate device

| 5.1 | Device Name | POWDER FREE STERILE VINYL EXAMINATION
GLOVE (Clear and Yellow) |
|-----|----------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| 5.2 | 510(k) Number | K 053523 |
| 5.3 | Company | Shijiazhuang Hongxiang Plastics Products Co Ltd
C/O Ms. Micky Lin, Gloveco, Inc. 3973 Schaefer Ave.
Chino, California 97710 |
| 5.4 | Device Description | POWDER FREE STERILE VINYL EXAMINATION
GLOVES(Clear and Yellow) |
| 5.5 | Classification | PATIENT EXAMINATION GLOVES |
| 5.6 | Class | CLASS I |
| 5.7 | Product code | LYZ |
| 5.8 | Classification Panel | General Hospital |

6.0 Description of the Device

The subject device is a vinyl examination glove made of synthetic poly vinyl chloride compound. It is sterile, POWDER FREE. The device is ambidextrous. The device meets ASTM D 5250-06: Standard specification for poly vinyl chloride gloves for medical application.

The device is for over-the counter single use.

7.0 Indications for use

The POWDER FREE patient examination gloves is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner

5

Summary of performance data 8.0

There is no difference in technological characteristics compared to the predicate device. Gloves are made from Poly vinyl chloride compound, sterile, POWDER FREE. The gloves have the same technological characteristics compared to ASTM or equivalent standards as given below,

| Characteristics | Standards | Performance of Sterile
Vinyl examination gloves,
POWDER FREE |
|---------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Freedom from Holes | ASTM D 5250-06/ ASTM
D5151-06 | Meets |
| Dimensions | ASTM D 5250-06 | Meets |
| Physical Properties | ASTM D 5250-06 / ASTM
D412-06 | Meets |
| POWDER FREE
residue | ASTM D 5250-06 | Meets |
| Bio-compatibility | Primary skin irritation
ISO 10993-10
Skin/Dermal Sensitization
ISO 10993-10 | Non-irritant
Non-sensitizer |
| Expiration
dating/Shelf life | ASTM D7160-05 | Three years |
| Sterility | ISO 11737-02 | Meets |

6

Performance data of gloves based on ASTM D 5250-06and FDA 1000ml water leak test

ASTM D 5250-06and FDA 1000 ml water leak test
Characteristics	Test	Test
standard	Sampling
plan/Inspect
ion
level/AQL	sterile, vinyl
examination
gloves -
PRIMUS	RESULT
Freedom from
Pin holes	FDA 1000 ml
water leak
test	ASTM D5151-
06 (reap

```
     | ISO 2859-1 /
```

11 Mpa
Ultimate
Elongation : >
300 % |
| After
Accelerated
aging | | ASTM D
5250-06and
ASTM D412-
06 | ISO 2859-1 /
S2/AQL 4.0 | Tensile
strength :
11 Mpa
Ultimate
Elongation : >
300 % | PASS |
| POWDER FREE
residue | POWDER
FREE
residue | ASTM D
5250-06and
ASTM D6124-
06 | N=5 | Less than 2 mg
per glove | PASS |
| Bio compatibility | Primary skin
irritation | ISO 10993-10 | Under the conditions of the
study the device is not an
irritant | | PASS |
| | Skin/Dermal
Sensitization | ISO 10993-10 | Under the conditions of the
study the device is not a
sensitizer | | PASS |
| Sterility | | ISO 11737-02 | Sterile | | Pass |

7

Predicate comparison chart 9.0

| Characteristics | PREDICATE – 510(K) :
K053523 | SUBJECT DEVICE | Acceptance
criteria/Standard |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Manufacturer | Shijiazhuang Hongxiang
Plastics Products Co Ltd
C/O Ms. Micky Lin, Gloveco,
Inc. 3973 Schaefer Ave.
Chino, California 97710 | PRIMUS GLOVES PRIVATE
LIMITED, Plot No: 14-A,
CSEZ, Kakkanad, Cochin,
Kerala, India -682037 | |
| Product Name | POWDER FREE STERILE
VINYL EXAMINATION
GLOVES(Clear and Yellow) | STERILE VINYL
EXAMINTION
GLOVES, POWDER FREE | Similar |
| Intended Use | The patient examination
gloves is a disposable device
intended for medical
purposes that is worn on the
examiners hand or finger to
prevent contamination
between patient and
examiner | The patient examination
gloves is a disposable device
intended for medical
purposes that is worn on the
examiners hand or finger to
prevent contamination
between patient and
examiner | Similar |
| Indication for
use | The patient examination
gloves is a disposable device
intended for medical
purposes that is worn on the
examiners hand or finger to
prevent contamination
between patient and
examiner | The patient examination
gloves is a disposable device
intended for medical
purposes that is worn on the
examiners hand or finger to
prevent contamination
between patient and
examiner | Similar |
| Description | POWDER FREE sterile Vinyl
Examination glove(clear and
yellow) is made of poly vinyl
chloride The gloves are
provided in Sizes Small,
Medium, Large and Extra
Large | sterile Vinyl Examination
gloves POWDER FREE is
made of poly vinyl chloride
The gloves are provided in
Sizes Small, Medium, Large
and Extra Large | Similar |
| Presentation | Sterile gloves are
provided in pouches | Sterile gloves are
provided in pouches | Similar |
| Material | Poly Vinyl Chlorid | Poly Vinyl Chlorid | Similar |
| Non-sterile or sterile | Sterile | Sterile | Similar |
| Single Use | Yes | Yes | Similar |
| Ambidextrous | Yes | Yes | Similar |
| Dimensions | Meets ASTM D 5250-
06 | Overall length min 230
mm ,width varies from
80 mm for small size
to 115 mm for Large
size, thickness in
finger 0.05 mm min
&,Palm 0.08 mm min | Similar |
| | | Tensile strength 11
Mpa min for before &
after aging
Aging done at 70 ±2
deg C for 72±2 hrs | Similar |
| Tensile Strength | Meets ASTM D 5250-
06 | | |
| Ultimate Elongation | Meets ASTM D 5250-
06 | Ultimate elongation
300 % min for before
& after aging. Aging
done at 70 ±2 deg C
for 72±2 hrs | Similar |
| Freedom from
pinholes | Meets ASTM D 5151 -
06 and ASTM D
5250-06 | Meets ASTM D 5151 -
06 (2011) and ASTM
D 5250-06 | Similar |
| Residual Powder | Meets ASTM D 6124-
06 | Less than 2 mg per
glove | Similar |
| Biocompatibility Tests | Non-irritant -Primary
Skin Irritation In
Rabbits | Under the conditions
of the study the device
is not an irritant | Similar |
| | ISO 10993-10 | Non-sensitizer - skin
Sensitization in
Guinea pigs | Under the conditions
of the study the device
is not a sensitizer |
| Labeling | POWDER FREE,
Vinyl Examination
glove
sterile
Single use only
Ambidextrous
Manufactured for
Lot No
Intended use
Quantity
Country of origin | *POWDER FREE,

Vinyl Examination
glove
sterile
*Single use only
Ambidextrous
*Manufactured for
*Lot No
*Intended use
*Quantity
*Country of origin | Similar |
| Sterility | Sterile | Sterile | Similar |

8

K170612

9

10

CONCLUSION 10.0

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.