Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a simple medical glove and the summary describes standard physical and performance testing, with no mention of AI/ML or related concepts.

Therapeutic

No
The device, Latex Examination Powder Free Gloves, is intended to prevent contamination between patient and examiner and is described as a disposable device for medical purposes, not for therapeutic intervention.

Diagnostic

No
Explanation: The device is Latex Examination Powder Free Gloves, described as a disposable device worn on the hand to prevent contamination. Its intended use is not for diagnosing a condition, but for protection.

SaMD (Software as a Medical Device)

No

The device is a physical product (gloves) and 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 clearly states the gloves are "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function performed in vitro (outside the body).
Device Description: The description focuses on the physical properties and manufacturing standards of the gloves, consistent with a barrier device.
Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting substances, or providing diagnostic information.
Performance Studies: The performance studies focus on the physical integrity and safety of the gloves (strength, water tightness, protein levels), not on diagnostic accuracy.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. These gloves do not perform any such function.

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 D3578-05 (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's hand / medical purpose

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 tests meet following standards:

ASTM D3578-05 (Reapproved 2015) Standard Specification for Rubber Examination Gloves
ASTM D5151-06 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves
ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
ASTM D5712-95 (Reapproved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Length: X-Small 236 mm, Small 236 mm, Medium 242 mm, Large 248 mm, X-Large 252 mm (Min 230 mm for all sizes)
Width: X-Small 76 mm, Small 85 mm, Medium 98 mm, Large 106 mm, X-Large 116 mm (X-Small 70+/-10 mm, Small 80+/-10mm, Medium 95+/-10 mm, Large 111+/-10 mm, X-Large 115+/-10 mm)
Thickness: Palm 0.12mm, Finger 0.14mm for all sizes (Palm 0.08 mm min, Finger 0.08 mm min for all sizes)
Tensile Strength (Before Ageing): X-Small 22.08 Mpa, Small 22.16 Mpa, Medium 22.22 Mpa, Large 22.30 Mpa, X-Large 22.32 Mpa (18Mpa Min for all sizes)
Tensile Strength (After Ageing): X-Small 18.50 Mpa, Small 18.56 Mpa, Medium 18.65 Mpa, Large 18.74 Mpa, X-Large 18.76 Mpa (14Mpa Min for all sizes)
Ultimate Elongation (Before Ageing): X-Small 856%, Small 868%, Medium 874%, Large 880%, X-Large 882% (650% Min for all sizes)
Ultimate Elongation (After Ageing): X-Small 842%, Small 850%, Medium 855%, Large 860%, X-Large 862% (500% Min for all sizes)
Stress at 500% Elongation (Before Ageing): X-Small 5.1 Mpa, Small 5.1 Mpa, Medium 5.2 Mpa, Large 5.2 Mpa, X-Large 5.2 Mpa (5.5 Mpa Max for all sizes)
Holes in the gloves: Passes AQL 1.5 (AQL 2.5)
Residual Powder: X-Small 0.21 mg/glove, Small 0.21 mg/glove, Medium 0.22 mg/glove, Large 0.22 mg/glove, X-Large 0.22 mg/glove (2 Mg/Glove Max)
Extractable Protein: 32 µg/ dm² for all sizes (200 µg/ dm² Max for all sizes)
Bacterial Endotoxin test:

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 & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the full name of the agency, "U.S. Food & Drug Administration," in a smaller font size.

September 20, 2021

Aspen Glove Sdn. Bhd. % Manoj Zacharias Consultant Liberty Mangement Group Ltd. 75 Executive Dr. STE114 Aurora, Illinois 60504

Re: K211477

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: August 16, 2021 Received: August 16, 2021

Dear Manoj Zacharias:

We have reviewed vour 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 Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical And Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211477

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)

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510K SUMMARY

As required by 21CFR§807.92(c)

A. APPLICANT INFORMATION

Applicant	Aspen Glove Sdn. Bhd.
Address	Aspen House, 300, JLN Macalister,
10450 Georgetown, Pulau Pinang,
Malaysia
Phone	+604- 227 5000
Fax	+604- 227 5000
E-mail	corporate@aspen.com.my
Contact Person	Mr. Iskandar Basha bin Abdul Kadir
Designation	Managing Director
Contact Number	017 -550 0577
Contact Email	Iskandar@aspenglove.com.my
Date Submitted	APRIL 25th, 2021

B. DEVICE IDENTIFICATION

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

C. PREDICATE DEVICE

| Legally Marketed devices

that Equivalency is claimed	JR Medic Powder free Latex Examination Gloves
510(K) Number	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 D3578-05 (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. TECHNOLOGICAL CHARACTERISTICS

Characteristics	Standards	Device Performance		Comparison
		Predicate	Current
510(K) Number	---	K192329	K211477	---
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 | | | | | | | | | | | | |
| | | | Size Average X-Small 236 Small 236 Medium 242 Large 248 X-Large 252 | | | | | | | | | | | | | |
| Dimensions- Width | ASTMD3578-05
(Reapproved
| Width Min 95+/-
10 mm (for
medium size) | Width Min 95+/-10
mm (for medium size) | Similar | | | | | | | | | | | | |
| | | | Size Average X-Small 76 Small 85 Medium 98 Large 106 X-Large 116 | | | | | | | | | | | | | |
| Physical
Properties-
Tensile
Strength | ASTMD3578-05
(Reapproved
| Before Ageing
Tensile Strength

18 Mpa | Before Ageing
Tensile Strength > 18 Mpa | Similar | | | | | | | | | | | | |
| | | | Size Actual value X-Small 22.08 Small 22.16 Medium 22.22 Large 22.30 X-Large 22.32 | | | | | | | | | | | | | |
| | | After Ageing
Tensile
Strength
14 Mpa | After Ageing
Tensile Strength > 14 Mpa | Similar | | | | | | | | | | | | |
| | | | Size Actual value X-Small 18.50 Small 18.56 Medium 18.65 Large 18.74 X-Large 18.76 | | | | | | | | | | | | | |

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Characteristics	Standards	Device Performance
		Predicate	Current
510(K) Number		K192329
Physical Properties-
Ultimate Elongation	ASTMD3578-05
(Reapproved 2015)	Before Ageing
Ultimate Elongation

650% | Before Ageing
Ultimate Elongation > 650%
Size Actual value X-Small 856 Small 868 Medium 874 Large 880 X-Large 882 | | | | | | | | | | | | | Similar | | | | | | |
| | | After Ageing
Ultimate Elongation
500% | After Ageing
Ultimate Elongation > 500%
Size Actual value X-Small 842 Small 850 Medium 855 Large 860 X-Large 862 | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | |
| Thickness | ASTMD3578-05
(Reapproved 2015) | Palm > 0.08 mm
Finger > 0.08 mm | Palm > 0.08 mm
Finger > 0.08 mm
Size Palm
(Actual value) Finger
(Actual value) X-Small 0.12 0.14 Small 0.12 0.14 Medium 0.12 0.14 Large 0.12 0.14 X-Large 0.12 0.14 | | | | | | | | | | | | | | | | | | | Similar |
| Powder Free Residue | ASTMDD 3578-10
(Reapproved 2015) | | No data available | ASTM D3578-05 (Reapproved 2015) Standard Specification for Rubber Examination Gloves

ASTM D5151-06 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves
ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
ASTM D5712-95 (Reapproved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber

H. CONCLUSION

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission Latex Examination Powder Free Gloves is as effective, and performs as well as or better than the legally marketed predicate device K192329.