Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein

• K Number: K202401
• Device Name: Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein
• Manufacturer: ECO Medi Glove Sdn. Bhd
• Date Cleared: 2021-02-17 ( 180 days)
• Product Code: KGO
• Regulation Number: 878.4460

Intended Use

Powder Free NR Latex Surgical Glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Description

The subject device in this 510(k) Notification is Latex Surgeon's Glove Powder Free with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein. The subject device is a Surgeon's glove made from compounded primarily Natural Latex, Yellow, powder free and sterile (Per 21 CFR 878.4460, class I. The device meets all the specifications in ASTM 3577-09, Standard specification for Rubber Surgical Glove. Additionally, the gloves have been tested for biocompatibility. Latex Surgeon's Gloves Powder Free with Protein content labelling claims 50ug/dm² or less per glove of extractable Protein is classification as Type 1: Glove compounded primarily form Natural Rubber Latex The Proposed device is sterilized using Gamma irradiation method to achieve the sterility Assurance Level (SAL) of 10E and place in a sterility maintenance package to ensure a shelf life of 3 years Powder Free NR Latex Surgical Glove (Sterile), is a disposable device intended for medical purposes that is worn by operating room personal to protect a surgical wound from contamination (product Code KGO).

Predicate Devices

K190632

Reference Devices

K190632

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties, sterility, and biocompatibility of a latex surgical glove. There is no mention of AI or ML technology.

Therapeutic

No
The device is a surgical glove intended to protect a surgical wound from contamination, not to treat or cure a disease or condition.

Diagnostic

No

This device is a surgical glove designed to protect a wound from contamination, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device is a physical surgical glove made of natural rubber latex, 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 is to protect a surgical wound from contamination by being worn by operating room personnel. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
• Device Description: The description focuses on the material (natural rubber latex), physical properties (powder-free, sterile), and performance characteristics related to its use as a surgical glove (meeting ASTM standards, biocompatibility, sterility). There is no mention of analyzing samples from the body or providing diagnostic information.
• 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 the diagnosis, monitoring, or treatment of a disease or condition.

The device is clearly described as a surgical glove, which is a medical device used for protection and barrier purposes in a surgical setting.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Powder Free NR Latex Surgical Glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Product codes

KGO

Device Description

The subject device in this 510(k) Notification is Latex Surgeon's Glove Powder Free with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein. The subject device is a Surgeon's glove made from compounded primarily Natural Latex, Yellow, powder free and sterile (Per 21 CFR 878.4460, class I. The device meets all the specifications in ASTM 3577-09, Standard specification for Rubber Surgical Glove. Additionally, the gloves have been tested for biocompatibility.

Latex Surgeon's Gloves Powder Free with Protein content labelling claims 50ug/dm² or less per glove of extractable Protein is classification as Type 1: Glove compounded primarily form Natural Rubber Latex

The Proposed device is sterilized using Gamma irradiation method to achieve the sterility Assurance Level (SAL) of 10E and place in a sterility maintenance package to ensure a shelf life of 3 years

Powder Free NR Latex Surgical Glove (Sterile), is a disposable device intended for medical purposes that is worn by operating room personal to protect a surgical wound from contamination (product Code KGO).

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 personal

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

Non-clinical testing was performed based on ASTM D3577-09 and FDA 1000ml water leak test.
The gloves have the same technological characteristics compared to ASTM or equivalent standards:

• Freedom from Holes: ASTM D3577-09 / ASTM D5151-06; Meets AQL 1.5; PASS
• Dimensions: ASTM D3577-09; For length, Min 265mm; For width, 70±6 mm to 114±6 mm (sizes 5.5 to 9.0); For thickness, >0.10mm (cuff, palm, finger); PASS
• Physical Properties: ASTM D3577-09 / ASTM D412-06; Before aging: Tensile strength > 24 Mpa, Ultimate Elongation > 750%; After Accelerated aging: Tensile strength > 18 Mpa, Ultimate Elongation > 560%; PASS
• Powder-free residue: ASTM D6124-06; Less than 2 mg per glove; PASS
• Powder Content: ASTM D 5712, ASTM D 6499-12; Less than 2 mg per glove; PASS
• Bio-compatibility: Primary skin irritation - ISO 10993-10 (Non-irritant); Skin Sensitization - ISO 10993-10 (Non-sensitizer); Acute Systemic Test (Non Toxic); PASS
• Expiration dating/Shelf life: ASTM D7160-05; Three years
• Sterilization: ISO 11737-Sterilization of medical device-Microbiological method - part 1; 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; PASS

Key Metrics

• Tensile Strength (MPa): 24 MPa minimum (Before Ageing), 18 MPa minimum (After Aging)
• Ultimate Elongation (%): 750% minimum (Before Ageing), 560% minimum (After Aging)
• Pin-hole Level: AQL 1.5 Inspection Level G-1
• Powder content:

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 shows 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 17, 2021

ECO Medi Glove Sdn. Bhd Suresh Kumar OA Manager Lot 26910, Lorong Perusahaan 3/3, Kawasan Perusahaan, Kamunting Raya Taiping, Perak 34600 Malaysia

Re: K202401

Trade/Device Name: Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: August 1, 2020 Received: August 21, 2020

Dear Suresh Kumar:

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 and Part 809); 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 medical devices and radiation-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 ([e-mail]) or phone [phone] 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K 202401

Device Name

Powder Free NR Latex Surgical Glove (Sterile)with protein content labeling claims 50ug/dm2 or less per glove of extractable protein.

Indications for Use (Describe)

Powder Free NR Latex Surgical Glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

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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FORM FDA 3881 (7/17)

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510(K) Summary Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claim 50ug/dm² or less per glove of extractable Protein

1.0 Submitter:

4.0 Predicate De vice Information:

Latex Surgeon's Gloves Powder Free with Protein content labelling claims 50ug/dm² or less per glove of extractable Protein, 79KGO, which meets all the requirement of ASTM D 3577-09 and FDA 21 CFR 878.4460. It is equivalent to K190632, Latex surgeon's Glove Powder Free with Protein content labeling claim of 50ug/dm² or less per glove of extractable protein

5.0 Indication For Use

Powder Free NR Latex Surgical Glove is a device made of Natural Rubber Intended to be worn by operating room personal to protect a surgical wound from contamination

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6.0 Device Description

The subject device in this 510(k) Notification is Latex Surgeon's Glove Powder Free with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein. The subject device is a Surgeon's glove made from compounded primarily Natural Latex, Yellow, powder free and sterile (Per 21 CFR 878.4460, class I. The device meets all the specifications in ASTM 3577-09, Standard specification for Rubber Surgical Glove. Additionally, the gloves have been tested for biocompatibility.

Latex Surgeon's Gloves Powder Free with Protein content labelling claims 50ug/dm² or less per glove of extractable Protein is classification as Type 1: Glove compounded primarily form Natural Rubber Latex

The Proposed device is sterilized using Gamma irradiation method to achieve the sterility Assurance Level (SAL) of 10E and place in a sterility maintenance package to ensure a shelf life of 3 years

Powder Free NR Latex Surgical Glove (Sterile), is a disposable device intended for medical purposes that is worn by operating room personal to protect a surgical wound from contamination (product Code KGO).

7.0 Specification for Rubber Surgical gloves:

Dimension/Size	5.5	6.0	6.5	7.0	7.5	8.0	8.5	9.0
Overall Length (mm) (Minimum)	265	265	265	265	265	265	265	265
Width (± 6mm)	70	76	83	89	95	102	108	114
Thickness at Palm (mm) (Minimum)	0.10	0.10	0.10	0.10	0.10	0.10	0.10	0.10
Thickness at Finger Tip (mm) (Minimum)	0.10	0.10	0.10	0.10	0.10	0.10	0.10	0.10
Thickness at cuff (mm) (Minimum)	0.10	0.10	0.10	0.10	0.10	0.10	0.10	0.10

7.1 Dimension and Thickness of Gloves

7.2 Gloves Physical Properties and Holes

| Measurement | Before Ageing | After Aging at 70°C for
168 hrs. @ 100°C for 22
hrs. |
|-------------------------|---------------------------------|------------------------------------------------------------|
| Tensile Strength (MPa) | 24 MPa minimum | 18 MPa minimum |
| Ultimate Elongation (%) | 750% minimum | 560% minimum |
| Pin-hole Level | AQL 1.5
Inspection Level G-1 | AQL 1.5
Inspection Level G-1 |

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8.0 Technological Characteristics Comparison

| Characteristics | Powder Free NR Latex Surgical Glove
(Sterile) with Protein content labelling
claims 50ug/dm² or less per glove of
extractable Protein
K202401 (Subject Device)
Eco Medi Glove Sdn. Bhd.
KGO | Latex surgeon's Glove Powder Free with
Protein content labeling claim of 50ug/dm² or
less per glove of extractable protein
K190632 (Predicate Device)
Lenora Glove Pvt. Ltd
KGO | Comparison |
|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended use | Powder Free NR latex Surgical Glove is a
device made of Natural Rubber intended to be
worn by operating room personal to protect a
surgical wound from contamination | Surgeons glove is a device made of natural rubber
intended to be worn by operating room personal
to protect a surgical wound from contamination | Same |
| Description | Sterile Powder free, surgical
gloves are made of natural
rubber latex. The gloves are
provided in Sizes 5.5 6.0, 6.5, 7.0, 7.5,
8.0, 8.5 and 9.0 | Sterile Powder free, surgical
gloves are made of natural
rubber latex. The gloves are
provided in Sizes 5.5,6.0, 6.5, 7.0, 7.5, 8.0,
8.5 and 9.0 | Same |
| Presentation | Sterile gloves are provided in pouches | Sterile gloves are provided in pouches | Same |
| Anatomic | Yes | Yes | Same |
| Material use | Natural Rubber Latex | Natural Rubber Latex | Same |
| Colour | Yellow | Natural (No color is added) | Different |
| Sterility | Sterile | Sterile | Same |
| Single used | Single used | Single used | Same |
| Non-Sterile or Sterile | Sterile | Sterile | Same |
| Dimensions | Meets ASTM D3577 - 09 | Meets ASTM D3577 - 09 | Similar |
| Physical properties | Meets ASTM D3577 -09 and
ASTM D412, D573. | Meets ASTM D3577 -09 and
ASTM D412, D573. | Similar |
| Freedom from pinholes | Meets ASTM D 5151 -06
and ASTM D3577- 09 | Meets ASTM D 5151 -06
and ASTM D3577- 09 | Same |
| Characteristics | Powder Free NR Latex Surgical Glove
(Sterile) with Protein content labelling
claims 50ug/dm² or less per glove of
extractable Protein,K202401 | Latex surgeon's Glove Powder Free with
Protein content labeling claim of 50ug/dm² or
less per glove of extractable protein, K190632
(Predicate Device) | Comparison |
| Residual Powder | Meets ASTM
D6124-06, (Reapproved
2017)
Powder content 0.10mm
(cuff, palm
,finger) | PASS |
| Powder Content | ASTM D 5712, ASTM D 6499-12 | Meets | Physical
properties | Before aging | ASTM D3577-09
and ASTM D412-
06 | ISO 2859-1 /
S2/AQL 4.0 | Tensile
strength :

24 Mpa
Ultimate
Elongation
: >750% | PASS |
| Bio-compatibility | Primary skin irritation - ISO 10993-10 | Non-irritant | | After
Accelerated
aging | ASTM D3577-09
and ASTM D412-
06 | ISO 2859-1 /
S2/AQL 4.0 | Tensile
strength :
18 Mpa
Ultimate
Elongation :
560% | PASS |
| | Skin Sensitization - ISO 10993-10 | Non-sensitizer | Powder-free
residue | Powder-free
residue | ASTM D3577-09
and
ASTM D6124-06 | N=5 | Less than 2
mg per
glove | PASS |
| | Acute Systemic Test | Non Toxic | Powder Content | Powder
Residue | ASTM D 5712,
ASTM D 6499-12 | N=5 | Less than 2
mg per
glove | PASS |
| Expiration dating/
Shelf life | ASTM D7160-05 | Three years | Biocompatibility | Primary skin
irritation | ISO 10993 -10 | Under the conditions of the
study the device is not an
irritant | | PASS |
| Sterilization | ISO 11737-Sterilization of medical
device-Microbiological method - part 1 | Meets | | Skin
Sensitization | ISO 10993 -10 | Under the conditions of the
study the device is not a
sensitizer | | PASS |
| 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 | Sterility | Sterility | ISO-11737-2 | Sterile | | PASS |

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Performance data of gloves based on ASTM D3577-09 and FDA 1000ml water leak test

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10.0 Conclusion

Based on intended uses, technological characteristics and non - clinical performance data, the Latex Surgeon's Gloves Powder Free with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein is as safe, as effective, and performs as well as the legally marketed predicate device, Latex surgeon's Glove Powder Free with Protein content labeling claim of 50ug/dm2 or less per glove of extractable protein, K190632