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 biocompatibility of latex gloves, with no mention of AI or ML.

Therapeutic

No
Explanation: The device is described as disposable gloves intended to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic one. It does not treat or alleviate a disease or condition.

Diagnostic

No
Explanation: The device, Latex Examination Powder Free Gloves, is intended to prevent contamination between patient and examiner. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition. Its purpose is protective, not analytical.

SaMD (Software as a Medical Device)

No

The device is a physical product (gloves) and the description focuses on material properties and performance testing of the physical gloves, not software.

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 clearly states the gloves are for preventing contamination between patient and examiner by being worn on the hand. This is a physical barrier function, not a diagnostic test performed on a sample from the body.
Device Description: The description focuses on the material (Natural Rubber Latex) and manufacturing standards for examination gloves. There is no mention of reagents, assays, or any components used to analyze biological samples.
Lack of IVD Characteristics: The document 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 of diseases or conditions.

The device is a medical device, specifically a Class I or Class II medical 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

Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

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

LYY

Device Description

Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D 3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (no color is added) and are powder free.

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

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)

Non-clinical performance data was summarized, including tests for:

Length (ASTM D3578-05): Min 230 mm for all sizes. Results: X-Small: 303 mm, Small: 304mm, Medium: 304mm, Large: 305mm.
Width (ASTM D3578-05): X-Small: 70+/-10 mm, Small: 80+/-10mm, Medium: 95+/-10 mm, Large: 111+/-10 mm. Results: X-Small: 75 mm, Small: 84 mm, Medium: 94mm, Large: 105mm.
Thickness (ASTM D3578-05): Palm 0.08 mm min, Finger 0.08 mm min for all sizes. Results: Palm 0.16mm for all sizes (X-Small, Small, Medium, Large), Finger 0.21mm for all sizes.
Physical properties - Tensile strength (ASTM D3578-05): Before Ageing Tensile Strength 18Mpa Min, After Ageing Tensile Strength 14Mpa Min. Results (Before ageing): X-Small: 22.13Mpa, Small: 22.20Mpa, Medium: 22.25Mpa, Large: 22.28Mpa. Results (After ageing): X-Small: 18.57Mpa, Small: 18.64Mpa, Medium: 18.70Mpa, Large: 18.74Mpa.
Physical properties - Ultimate Elongation (ASTM D3578-05): Before Ageing Ultimate elongation 650% Min, After Ageing Ultimate Elongation 500% Min. Results (Before ageing): X-Small: 867%, Small: 871%, Medium: 874%, Large: 877%. Results (After ageing): X-Small: 845%, Small: 848%, Medium: 854%, Large: 860%.
Physical properties - Stress at 500% Elongation (ASTM D3578-05): Before Ageing 5.5 Mpa Max. Results (Before ageing): X-Small: 5.1 Mpa, Small: 5.1Mpa, Medium: 5.2 Mpa, Large: 5.2Mpa.
Water Tight (ASTM D5151-06): Passes AQL-1.5. Results: Gloves Passes AQL 1.5.
Residual Powder (ASTM D6124-06): 2 Mg/Glove Max. Results: X-Small: 0.21 mg/glove, Small: 0.21 mg/glove, Medium: 0.22 mg/glove, Large: 0.22 mg/glove.
Extractable Protein (ASTM D 5712-95): 200 µg/ dm² Max. Results: X-Small: 50 µg/ dm², Small: 50 µg/ dm², Medium: 50 µg/ dm².

Biocompatibility tests showed the device to be:

Not an irritant (Primary Skin Irritation-ISO 10993-10:2010(E))
Not a sensitizer (Dermal Sensitization- ISO 10993-10:2010(E))
Non-cytotoxic (In vitro cytotoxicity ISO10993-5:2009(E))
Non pyrogenic (Material mediated Pyrogenicity ISO 10993-11:2017(E) / USP 41)
Not systemically toxic (Acute Systemic Toxicity Test ISO 10993-11:2017(E)).

Key results: The nonclinical tests demonstrate that the subject device (K202377) is as safe, as effective, and performs as well as or better than the legally marketed predicate device K192329.

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.

K192329

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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."

December 1, 2020

Hi-Care Thai Gloves Co. Ltd. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504

Re: K202377

Trade/Device Name: Latex Examination Powder Free Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LYY Dated: October 31, 2020 Received: November 3, 2020

Dear Manoj Zacharias:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For: CAPT Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202377

Device Name Latex Examination Powder Free Gloves

Indications for Use (Describe)

Latex Examination Powder Free Gloves are disposable device intended for medical purpose that is worn on the examiner's hand 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)

Description 303 (Part 21, SFAR 36, Subpart B)

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

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510K SUMMARY

K202377

As required by 21CFR§807.92(c)

A. APPLICANT INFORMATION

Applicant	Hi-Care Thai Gloves Co. Ltd.
Address	199Moo.11, T.Banpru, A.Hatyai, Songkhla 90250, Thailand.
Phone	+66-92 225 8472
Fax	+66-74-291044
E-mail	daniel@hicarethai.com
Contact Person	Mr. Daniel John
Designation	International Operations Manager,
Contact Number	+66-92 225 8472
Contact Email	daniel@hicarethai.com
Date Submitted	August 5th, 2020

B. DEVICE IDENTIFICATION

Name of the device	Latex Examination Powder Free Gloves
Proprietary or trade name	Palm Care Latex Examination Powder Free Gloves
Common or usual name	Latex Examination Powder Free Gloves
Classification name	Patient Examination Glove
Device Classification	Class I
Product Code	LYY
Regulation Number	21 CFR 880.6250
Review Panel	General Hospital

C. PREDICATE DEVICE

Predicate device	JR Medic Powder Free Latex Examination Gloves
Predicate 510(K)	K192329
Regulatory Class	Class I
Product code	LYY

D. DESCRIPTION OF THE DEVICE

Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D 3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (no color is added) and are powder free.

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E. INDICATIONS FOR USE/INTENDED USE OF THE DEVICE:

Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

F. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS BETWEEN PREDICATE AND SUBJECT DEVICES

CHARACTERSTICS	STANDARDS	DEVICE PERFORMANCE
		PREDICATE	CURRENT
510(k) Number		K192329	K202377
Name of device	---	JR MEDIC Blue
Latex
Examination
Powder Free
Gloves	Latex Examination Powder Free
Gloves	---
Dimensions- Length	ASTMD3578-05
(Reapproved

                                      | Length > 230 mm                                                                                                                                                                                                                 | Length > 230 mm                                                                                                                                                                                          | Similar                                            |            |

18 Mpa_
After Ageing
Tensile Strength
14 Mpa | Before Ageing
Tensile Strength > 18 Mpa | Similar | |
| | | | Size
X-Small
Small
Medium
Large | | |
| | | | Actual value
22.13
22.20
22.25
22.28 | | |
| | | | After Ageing
Tensile Strength > 14 Mpa | Similar | |
| | | | Size
X-Small
Small
Medium
Large | | |
| | | | Actual value
18.57
18.64
18.70
18.74 | | |
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | | COMPARISON |
| | | PREDICATE | | CURRENT | |
| 510(K) Number | | K192329 | | K202377 | |
| Physical Properties-
Ultimate Elongation | ASTMD3578-05
(Reapproved 2015) | Before Ageing
Ultimate Elongation
650%
After Ageing
Ultimate Elongation
500% | | Before Ageing
Ultimate Elongation > 650% | Similar |
| | | | Size | Actual value | |
| | | | X-Small | 867 | |
| | | | Small | 871 | |
| | | | Medium | 874 | |
| | | | Large | 877 | |
| | | | | After Ageing
Ultimate Elongation > 500% | |
| | | | Size | Actual value | |
| | | | X-Small | 845 | |
| | | | Small | 848 | |
| | | | Medium | 854 | |
| | | | Large | 860 | |
| Thickness | ASTMD3578-05
(Reapproved 2015) | Palm > 0.08 mm
Finger > 0.08 mm | | Palm > 0.08 mm
Finger > 0.08 mm | Similar |
| | | | Size | Palm
(Actual value)
Finger
(Actual value) | |
| | | | X-Small | 0.16
0.21 | |
| | | | Small | 0.16
0.21 | |
| | | | Medium | 0.16
0.21 | |
| | | | Large | 0.16
0.21 | |
| Powder Free Residue | ASTMDD 3578-10
(Reapproved2015) | $≤$ 2 mg/glove | $≤$ 2 mg/glove | | Similar |
| | | | Size | Residual
powder content
(mg/glove) | |
| | | | X-Small | 0.21 | |
| | | | Small | 0.21 | |
| | | | Medium | 0.22 | |
| | | | Large | 0.22 | |
| Biocompatibility | Primary Skin
Irritation-ISO
10993-10:2010(E) | Under the condition
of study, not an
irritant | Under the condition of study, not
an irritant | | Same |
| | Dermal Sensitization-
ISO 10993-
10:2010(E) | Under the conditions
of the study, not a
sensitizer | Under the conditions of the
study, not a sensitizer | | Same |
| | In vitro
cytotoxicity
ISO10993-5
:2009(E) | Under the conditions
of the study,
non-cytotoxic | Under the conditions of the
study, non-cytotoxic | | Same |
| | Material mediated
Pyrogenicity
ISO 10993-
11:2017(E) / USP
41 | Under the
conditions of the
study non pyrogenic | Under the conditions of the
study, non-pyrogenic | | Same |
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON | |
| | | PREDICATE | CURRENT | | |
| 510(K) Number | | K192329 | K202377 | --- | |
| Biocompatibility | Bacterial Endotoxin
test
USP 42 | No data available |