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

K202401 · Eco Medi Glove Sdn. Bhd. · KGO · Feb 17, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202401
• Device Name: Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein
• Applicant: Eco Medi Glove Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Feb 17, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

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 Story

Disposable, sterile, powder-free natural rubber latex surgical glove; intended for use by operating room personnel to protect surgical wounds from contamination. Device is yellow, anatomic, and provided in various sizes. Sterilized via gamma irradiation to achieve a sterility assurance level of 10^-6; packaged to ensure a 3-year shelf life. Device acts as a physical barrier between the clinician and the patient's surgical site. Performance is verified through physical property testing (tensile strength, elongation), pinhole leak testing, and biocompatibility assessments.

Clinical Evidence

Bench testing only. No clinical data. Performance verified against ASTM D3577-09 (dimensions, physical properties), ASTM D5151-06 (pinholes), ASTM D6124-06 (powder residue), and ISO 10993-10 (biocompatibility: primary skin irritation and dermal sensitization). All tests passed.

Technological Characteristics

Material: Natural rubber latex. Form: Sterile, powder-free, anatomic surgical glove. Dimensions: 265mm length, 0.10mm minimum thickness. Sterilization: Gamma irradiation. Standards: ASTM D3577-09, ASTM D5151-06, ASTM D6124-06, ASTM D412, ASTM D573, ISO 10993-10, ISO 11737.

Indications for Use

Indicated for operating room personnel to protect surgical wounds from contamination. Device is a sterile, powder-free, natural rubber latex surgical glove.

Regulatory Classification

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.

Predicate Devices

• Latex surgeon's Glove Powder Free with Protein content labeling claim of 50ug/dm2 or less per glove of extractable protein (K190632)

Submission Summary (Full Text)

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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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# 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<br>168 hrs. @ 100°C for 22<br>hrs. |
|-------------------------|---------------------------------|------------------------------------------------------------|
| Tensile Strength (MPa) | 24 MPa minimum | 18 MPa minimum |
| Ultimate Elongation (%) | 750% minimum | 560% minimum |
| Pin-hole Level | AQL 1.5<br>Inspection Level G-1 | AQL 1.5<br>Inspection Level G-1 |

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# 8.0 Technological Characteristics Comparison

| Characteristics | Powder Free NR Latex Surgical Glove<br>(Sterile) with Protein content labelling<br>claims 50ug/dm² or less per glove of<br>extractable Protein<br>K202401 (Subject Device)<br>Eco Medi Glove Sdn. Bhd.<br>KGO | Latex surgeon's Glove Powder Free with<br>Protein content labeling claim of 50ug/dm² or<br>less per glove of extractable protein<br>K190632 (Predicate Device)<br>Lenora Glove Pvt. Ltd<br>KGO | Comparison |
|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended use | Powder Free NR latex Surgical Glove is a<br>device made of Natural Rubber intended to be<br>worn by operating room personal to protect a<br>surgical wound from contamination | Surgeons glove is a device made of natural rubber<br>intended to be worn by operating room personal<br>to protect a surgical wound from contamination | Same |
| Description | Sterile Powder free, surgical<br>gloves are made of natural<br>rubber latex. The gloves are<br>provided in Sizes 5.5 6.0, 6.5, 7.0, 7.5,<br>8.0, 8.5 and 9.0 | Sterile Powder free, surgical<br>gloves are made of natural<br>rubber latex. The gloves are<br>provided in Sizes 5.5,6.0, 6.5, 7.0, 7.5, 8.0,<br>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<br>ASTM D412, D573. | Meets ASTM D3577 -09 and<br>ASTM D412, D573. | Similar |
| Freedom from pinholes | Meets ASTM D 5151 -06<br>and ASTM D3577- 09 | Meets ASTM D 5151 -06<br>and ASTM D3577- 09 | Same |
| Characteristics | Powder Free NR Latex Surgical Glove<br>(Sterile) with Protein content labelling<br>claims 50ug/dm² or less per glove of<br>extractable Protein,K202401 | Latex surgeon's Glove Powder Free with<br>Protein content labeling claim of 50ug/dm² or<br>less per glove of extractable protein, K190632<br>(Predicate Device) | Comparison |
| Residual Powder | Meets ASTM<br>D6124-06, (Reapproved<br>2017)<br>Powder content < 2 mg/Glove | Meets ASTM<br>D6124-06, (Reapproved<br>2017)<br>Powder content < 2 mg/Glove | Same |
| Protein Content | Meets ASTM D 5712, ASTM D 6499-12 &<br>ASTM D3577 | Meets ASTM D 5712, ASTM D 6499-12 &<br>ASTM D3577 | Same |
| Mode of<br>Sterilization | Irradiation | EO Sterilization/<br>Irradiation | Different |
| Biological Evaluation on<br>Medical Device<br>-Primary Skin Irritation<br>Test | Under the conditions of this study, the test<br>article was a non-irritant. | Under the conditions of this study, the test article<br>was a non-irritant. | Same |
| Biological Evaluation on<br>Medical Device-<br>Dermal Sensitization Assay | Under the conditions of this study, the test<br>article was a non-sensitizer. | Under the conditions of this study, the test article<br>was a non-sensitizer. | Similar |
| Acute Systemic Test | Non Toxic | Non Toxic | Same |
| Labelling | * Powder free<br>* Latex Surgical Glove<br>* Sterile<br>* Single use<br>* Anatomic<br>* Manufactured for<br>* Lot No<br>* Intended use<br>* Quantity<br>* Country of origin | * Powder free<br>* Latex Surgical Glove<br>* Sterile<br>* Single use Anatomic<br>* Manufactured for<br>* Lot No<br>* Intended use<br>* Quantity<br>* Country of origin | similar |

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The above table shows similarities and differences of the performance between the subject device and the predicate device. There are no major differences in technological characteristics of the subject device compare with the predicate device. There are only minor differences between the subject device and the predicate device. One difference is that the subject device is sterilized by Irradiation whereas the predicate device is sterilized by EO sterilization. These minor differences do not impact the intended use, safety and performance of the device. The gloves are made from Natural latex compound, Latex Surgeon's Gloves (Sterile).The gloves met all the specifications in ASTM D3577-09 Standard specification for Rubber Surgical Glove as well Biological Evaluation on medical device.

#### 9.0 SUMMARY OF NON-CLINICAL TESTING

Gloves are made from Latex compound, which is Sterile and Powder free. The gloves have the same technological characteristics compared to ASTM or equivalent standards as given below,

| Characteristics | Standards | Performance of<br>Sterile Latex<br>Surgical<br>Gloves, Powder free | Characteristics | Test | Test standard | Sampling<br>plan<br>/Inspection<br>level/AQL | Sterile Latex<br>Surgical<br>Gloves,<br>Powder free | Result |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|---------------------------|-----------------------------------|-----------------------------------------|------------------------------------------------------------------------|-------------------------------------------------------------------------|--------|
| Freedom from Holes | ASTM D3577-09 / ASTM D5151-06 | Meets | Freedom from<br>Pin holes | FDA 1000 ml<br>water leak<br>test | ASTM D5151 -06<br>(Re-approved<br>2011) | ISO 2859-1 /<br>G1/AQL 1.5 | Meet AQL<br>1.5 | PASS |
| Dimensions | ASTM D3577-09 | Meets | | Length | ASTM D3577 -09 | ISO 2859-1 /<br>S2/AQL 4.0 | Min 265 | PASS |
| Physical Properties | ASTM D3577-09 / ASTM D412-06 | Meets | Dimensions | Width | ASTM D3577-09 | ISO 2859-1 /<br>S2/AQL 4.0 | 70±6 mm to<br>114±6<br>mm (sizes 5.5<br>to 9.0) | PASS |
| Powder-free<br>residue | ASTM D6124-06 | Meets | | Thickness | ASTM D3577-09 | ISO 2859-1 /<br>S2/AQL 4.0 | >0.10mm<br>(cuff, palm<br>,finger) | PASS |
| Powder Content | ASTM D 5712, ASTM D 6499-12 | Meets | Physical<br>properties | Before aging | ASTM D3577-09<br>and ASTM D412-<br>06 | ISO 2859-1 /<br>S2/AQL 4.0 | Tensile<br>strength :<br>> 24 Mpa<br>Ultimate<br>Elongation<br>: >750% | PASS |
| Bio-compatibility | Primary skin irritation - ISO 10993-10 | Non-irritant | | After<br>Accelerated<br>aging | ASTM D3577-09<br>and ASTM D412-<br>06 | ISO 2859-1 /<br>S2/AQL 4.0 | Tensile<br>strength :<br>> 18 Mpa<br>Ultimate<br>Elongation :<br>> 560% | PASS |
| | Skin Sensitization - ISO 10993-10 | Non-sensitizer | Powder-free<br>residue | Powder-free<br>residue | ASTM D3577-09<br>and<br>ASTM D6124-06 | N=5 | Less than 2<br>mg per<br>glove | PASS |
| | Acute Systemic Test | Non Toxic | Powder Content | Powder<br>Residue | ASTM D 5712,<br>ASTM D 6499-12 | N=5 | Less than 2<br>mg per<br>glove | PASS |
| Expiration dating/<br>Shelf life | ASTM D7160-05 | Three years | Biocompatibility | Primary skin<br>irritation | ISO 10993 -10 | Under the conditions of the<br>study the device is not an<br>irritant | | PASS |
| Sterilization | ISO 11737-Sterilization of medical<br>device-Microbiological method - part 1 | Meets | | Skin<br>Sensitization | ISO 10993 -10 | Under the conditions of the<br>study the device is not a<br>sensitizer | | PASS |
| Sterility | ISO 11737 -2<br>Sterilization of Medical Devices-<br>Microbiological<br>methods Part 2: Test of sterility<br>performed in the<br>definition, validation and maintenance<br>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