Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical medical device (surgical gloves) and its performance characteristics based on standard ASTM testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

No.
The device's intended use is to protect the surgical wound from contamination, which is a protective function, not a therapeutic one. It does not treat or cure a disease or condition.

Diagnostic

No

This device is a surgical glove, intended to protect a surgical wound from contamination, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device described is a physical product (surgical gloves) and does not involve any software component.

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 that the gloves are "intended to be worn by operating room personnel to protect a surgical wound from contamination." This is a barrier function for protection during a medical procedure.
Device Description: The description details the physical characteristics and manufacturing process of surgical gloves.
Performance Studies: The performance studies focus on the physical properties of the gloves (strength, holes, powder, protein, sterilization, and resistance to chemotherapy drugs), not on analyzing samples from the human body to provide diagnostic information.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.

IVD devices are specifically designed to perform tests on biological samples to gain insights into a person's health status. Surgical gloves, while medical devices, serve a different purpose of providing a physical barrier.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy:

Test Chemotherapy Drug (Concentration)	Minimum Breakthrough Detection Time in minutes
Fluorouracil (50.0mg/ml)	>240
Etoposide (20.0mg/ml)	>240
Cyclophosphamide (20.0mg/ml)	>240
Carmustine (3.3mg/ml)	13.2
Thiotepa (10.0mg/ml)	12.0
Paclitaxel (6.0mg/ml)	>240
Doxorubicin Hydrochloride (2.0mg/ml)	>240
Methotrexate (25.0mg/ml)	>240
Vincristine Sulfate (1.0mg/ml)	>240

"WARNING: Do not use Carmustine and Thiotepa"

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

KGO, LZC

Device Description

It is the powder-free variation of the class I sterile latex surgical gloves made by on-line polymer and anti-tack coating on inner and outer surface. The process modifies the surface istics and causes it to remain tack-free without the use of any dusting or donning powder. The device size comes in different sizes - 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0. Gloves meet the specification of ASTM D3577 with dimension as below: Patient Examination Gloves Specialty (21 CFR 88.6250, LZC)

Size	5.5	6.0	6.5	7.0	7.5	8.0	8.5	9.0
Length, min. mm	245	265
Thickness, min. mm					0.10
Width, ± 6 mm	70	76	83	89	95	102	108	114

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Operating room personnel in a care setting.

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)

The performance test data of the non-clinical test that support a determination of substantial equivalence are the same as mentioned immediately above (ASTM requirement). Following standards were used for the testing:

ASTM D3577-09 Standard Specification for Rubber Surgical Gloves
ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves
ASTM D5712-15 Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method
ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves
ASTM D6978-16 Standard Assessment of Resistance of Medical Devices to Permeation
ISO 11137-2:2013 Sterilization of Healthcare Products- Establishing the sterilization dose

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.

K983489

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 27, 2021

Careplus (M) SDN BHD Lim Shyan CEO/Managing Director Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate Seremban, Negeri Sembilan 70450 Malaysia

Re: K202765

Trade/Device Name: ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: April 13, 2021 Received: April 16, 2021

Dear Lim Shyan:

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.

Ryan Ortega, PhD Acting 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) K202765

Device Name

ENCORE® Latex Textured Surgical Gloves, Powder free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs, Non-Pyrogenic

Indications for Use (Describe)

Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy:

Test Chemotherapy Drug (Concentration)	Minimum Breakthrough Detection Time in minutes
Fluorouracil (50.0mg/ml)	>240
Etoposide (20.0mg/ml)	>240
Cyclophosphamide (20.0mg/ml)	>240
Carmustine (3.3mg/ml)	13.2
Thiotepa (10.0mg/ml)	12.0
Paclitaxel (6.0mg/ml)	>240
Doxorubicin Hydrochloride (2.0mg/ml)	>240
Methotrexate (25.0mg/ml)	>240
Vincristine Sulfate (1.0mg/ml)	>240

"WARNING: Do not use Carmustine and Thiotepa"

Prescription Use (Part 21 CFR 801 Subpart D)

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

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K202765

1.0

510(K) SUMMARY

CAREPLUS (M) SDN BHD Applicant: Address: Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia. Phone No. 60-6-6772781 Fax No. 60-6-6772780 Contact Person Lim Kwee Shyan 2.0 Date of Summary 11th May, 2021 3.0 Device Information ENCORE® Latex Textured Surgical Gloves, Powder free with Protein Content Device Name: Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs, Non-Pyrogenic Common Name: Surgical Gloves Product Code: KGO Subsequent Product Code: LZC Classification Name: Surgeon's Gloves

4.0 Device Description

It is the powder-free variation of the class I sterile latex surgical gloves made by on-line polymer and anti-tack coating on inner and outer surface. The process modifies the surface istics and causes it to remain tack-free without the use of any dusting or donning powder. The device size comes in different sizes - 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0. Gloves meet the specification of ASTM D3577 with dimension as below:

Patient Examination Gloves Specialty (21 CFR 88.6250, LZC)

Size	5.5	6.0	6.5	7.0	7.5	8.0	8.5	9.0
Length, min. mm	245	265
Thickness, min. mm					0.10
Width, ± 6 mm	70	76	83	89	95	102	108	114

5.0 Predicate Device

K983489, Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim), Ansell Perry. The device is a class I, Surgeon's Gloves, KGO, LZC powder-free..

6.0 Indication for Use

Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect aa surgical wound from contamination.

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7.0 Technological Comparison Table:

7.0 Technological Comparison Table:
Characteristics	ASTM Specification	Standard References	Subject Glove K202765
(ENCORE® Latex Textured Surgical Gloves, Powder free with Protein Content Labeling Claim (50 micrograms or less and Tested for use with Chemotherapy drugs, Non-Pyrogenic)	Predicate Device (Encore Mark IV Powder Free Surgical Gloves, Protein Labeling Claim, K983489)	Discussion
Freedom from holes	ASTM D3577
ASTM D5151	G-I, AQL 1.5	Meets ASTM D3577
Meets ASTM D5151	Meets ASTM D3577
Meets ASTM D5151	Same
Dimension	ASTM D3577				Same
Length (size: 5.5), mm		245 min	min. 295	Meet 245mm min
Length (size: 6.0), mm		265 min	min. 295	Meet 265mm min
Length (size: 6.5), mm		265 min	min. 296	Meet 265mm min
Length (size: 7.0), mm		265 min	min. 295	Meet 265mm min
Length (size: 7.5), mm		265 min	min. 296	Meet 265mm min
Length (size: 8.0), mm		265 min	min. 296	Meet 265mm min
Length (size: 8.5), mm		265 min	min. 297	Meet 265mm min
Length (size: 9.0), mm		265 min	min. 295	Meet 265mm min
Thickness (cuff), mm		0.10 min	min. 0.158	Meet 0.10mm min
Thickness (palm), mm		0.10 min	min. 0.220	Meet 0.10mm min
Thickness (finger), mm		0.10 min	min. 0.225	Meet 0.10mm min
Width (size: 5.5), mm		70 ± 6	73-75 mm	Meet 70 ± 6 mm
Width (size: 6.0), mm		76 ± 6	78-79 mm	Meet 76 ± 6 mm
Width (size: 6.5), mm		83 ± 6	83-84 mm	Meet 83 ± 6 mm
Width (size: 7.0), mm		89 ± 6	90-91 mm	Meet 89 ± 6 mm
Width (size: 7.5), mm		95 ± 6	96-97 mm	Meet 95 ± 6 mm
Width (size: 8.0), mm		102 ± 6	102-103 mm	Meet 102 ± 6 mm
Width (size: 8.5), mm		108 ± 6	107-109 mm	Meet 108 ± 6 mm
Width (size: 9.0), mm		114 ± 6	114-115 mm	Meet 114 ± 6 mm
Physical Properties
(Before Ageing)
i) Tensile Strength (Mpa)
ii) Ultimate Elongation (%)
iii) Stress at 500% Elongation
(After Ageing)
i) Tensile Strength (Mpa)
ii) Ultimate Elongation (%)	ASTM D3577	Min. 24
Min. 750
Max. 5.5

Min. 18
Min. 560 | min. 24
min. 780
max. 2.0

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| Chemotherapy Drug | ASTM D6978-05 | Subject Glove
(ENCORE® Latex Textured Surgical Gloves, Powder free with
Protein Content Labeling Claim (50 micrograms or less) and Tested
for use with Chemotherapy drugs, Non-Pyrogenic) |
|-------------------------------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Chemotherapy
Drug | Concentration | Minimum Breakthrough Detection Time (min) |
| Fluorouracil (Adrucil) | 50.0mg/ml | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 |
| Cyclophosphamide
(Cytoxan) | 20.0mg/ml | > 240 |
| *Carmustine (BCNU) | 3.3mg/ml | 13.2 |
| *Thiotepa | 10.0mg/ml | 12.0 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 |
| Doxorubicin
Hydrochloride | 2.0mg/ml | > 240 |
| Methotrexate | 25.0mg/ml | > 240 |
| Vincristine Sulfate | 1.0mg/ml | > 240 |

8.0 Summary of Non-Clinical Testing

The performance test data of the non-clinical test that support a determination of substantial equivalence are the same as mentioned immediately above (ASTM requirement).

Following standards were used for the testing:

ASTM D3577-09 Standard Specification for Rubber Surgical Gloves
ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves
ASTM D5712-15 Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method
ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves
ASTM D6978-16 Standard Assessment of Resistance of Medical Devices to Permeation
ISO 11137-2:2013 Sterilization of Healthcare Products- Establishing the sterilization dose

9.0 Summary of Clinical Testing

Clinical data is not needed for medical gloves or of most devices cleared by the 510(k) process.

10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.