Black Nitrile Powder Free Patient Examination Glove, Non Sterile

K212916 · Rimba Glove Sdn Bhd · LZA · Mar 24, 2022 · General Hospital

Device Facts

• Record ID: K212916
• Device Name: Black Nitrile Powder Free Patient Examination Glove, Non Sterile
• Applicant: Rimba Glove Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Mar 24, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A 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. These gloves are designed for single use only and should be disposed after use.

Device Story

Disposable, non-sterile, ambidextrous patient examination glove; manufactured from nitrile rubber. Surface treatment produces smooth finish for donning without powder. Finger-textured design. Used in clinical settings by healthcare professionals to provide a barrier against contamination between examiner and patient. Single-use only; disposed after use. Benefits include protection against cross-contamination during medical examinations.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D6319 (physical dimensions, tensile strength, elongation), ASTM D6124 (residual powder), ASTM D5151 (watertightness), and ISO 10993 series (biocompatibility: primary skin irritation, dermal sensitization, cytotoxicity, acute systemic toxicity).

Technological Characteristics

Material: Nitrile rubber. Design: Ambidextrous, finger-textured. Dimensions: Length >240mm, thickness 0.05-0.10mm. Standards: ASTM D6319 (physical properties/dimensions), ASTM D6124 (powder), ASTM D5151 (watertightness), ISO 10993 (biocompatibility). Non-sterile. No software or electronic components.

Indications for Use

Indicated for use as a disposable, non-sterile, ambidextrous patient examination glove worn by healthcare examiners to prevent cross-contamination between the examiner and the patient.

Regulatory Classification

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.

Predicate Devices

• Disposable Powder Free Nitrile Examination Glove, Black Color (K190942)

Submission Summary (Full Text)

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March 24, 2022

Rimba Glove SDN BHD % Michael Woude U. S agent Emergo Global Representative LLC, 2500 Bee Cave Road Building 1, Suite 300 Austin, Texas 78746

Re: K212916

Trade/Device Name: Black Nitrile Powder Free Patient Examination Glove, Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: February 13, 2022 Received: February 22, 2022

Dear Michael Woude:

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.

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

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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 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,

For BiFeng Oian, Ph.D. 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) K212916

Device Name BLACK NITRILE POWDER FREE PATIENT EXAMINATION GLOVE, NON STERILE

Indications for Use (Describe)

A 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. These gloves are designed for single use only and should be disposed after use.

Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 1.0 Sponsor:

2.0

| Company Name | : Rimba Glove Sdn Bhd |
|-----------------|-------------------------------------------------------------------------------------------------------|
| Company Address | : Plot 37, Medan Tasek, Tasek Industrial Area, 31400 Ipoh,<br>Perak, Malaysia. |
| Submitter: | |
| Name | : Zahari Bin Darus |
| Address | : Rimba Glove Sdn Bhd<br>Plot 37, Medan Tasek, Tasek Industrial Area, 31400 Ipoh, Perak,<br>Malaysia. |

Date of Summary Prepared: 20th Aug 2021 (Revised date: 23rd March 2022)

#### 3.0 Identification of the subject device:

| Trade Name | : Black Nitrile Powder Free Patient Examination Glove, Non-<br>Sterile |
|-----------------------|------------------------------------------------------------------------|
| Common Name | : Patient Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Device Classification | : 1 |
| Regulation Number | : 21 CFR 880.6250 |
| Product Code | : LZA. |

#### 3.0 Predicate Device:

Phone No.

Fax No.

#### K190942

Disposable Powder Free Nitrile Examination Glove, Black Color Company: Ever Growth (Vietnam) Co. Ltd.

: [phone]

: [phone]

#### 4.0 Description of The Device:

The powder free nitrile examination glove is manufactured from Nitrile rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand and it is a single use device.

| Design | : Ambidextrous (i.e. fit either hand) |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Colour | : Black. |
| Intended use | : Single Use and Non-Sterile |
| Finishing | : Finger Textured. |
| Performance | : See Section 7 – Summary of Non-Clinical Testing |
| Storage | : The product is kept away from direct sunlight and fluorescent<br>lighting and stored in an environment with temperature not<br>exceeding 40 degree C. |

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### Indication for use:

A 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. These gloves are designed for single use only and should be disposed after use.

### Information for "Powder Free" Claim:

The finished powder free gloves meet ASTM D6319 requirements and are tested in according to ASTM D6124 method for powder measurement (less than 2mg per glove).

### Glove Size and dimension:

Measurement is done as per ASTM D6319. Length is measured from the tip of the middle finger to the outside edge of the cuff. Width is measured at a level between the base of the index finger and the base of the thumb.

| Size | Palm Width (mm) | Length (mm) |
|---------|-----------------|-------------|
| X-Small | 70±10 | Minimum 240 |
| Small | 80+10 | Minimum 240 |
| Medium | 95+10 | Minimum 240 |
| Large | 110±10 | Minimum 240 |
| X-Large | 120±10 | Minimum 240 |

#### 5.0 Technological Characteristics Comparison of the Device:

Provided below is the technological comparison of the subject device vs the predicate device as shown in Table 1.

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### Table 1

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON<br>ANALYSIS |
|----------------------------------------------------------------------------------------------------------------------------------------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| | | PREDICATE<br>BLACK | SUBJECT DEVICE<br>BLACK | |
| 510(k) Number | - | K190942 | K212916 | |
| Manufacturer(s) | - | Ever Growth Enterprise<br>Corporation | Rimba Glove Sdn Bhd | |
| Material | ASTM D6319 | Nitrile | Nitrile | Same |
| Color | - | Black | Black | Same |
| Class | - | Class 1 | Class 1 | Same |
| Product Code | - | LZA | LZA | Same |
| Regulation | - | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Physical Properties<br>Before Aging<br>Tensile Strength:<br>Ultimate Elongation:<br>After Aging<br>Tensile Strength:<br>Ultimate Elongation: | ASTM D6319 | 14Mpa, min<br>500% min<br>14Mpa, min<br>400% min | 30.9Mpa<br>583%<br>34.2Mpa<br>538% | Different but within<br>the ASTM standard<br>Different but within<br>the ASTM standard |
| Physical Dimension:<br>Thickness:<br>- Finger<br>- Palm<br>- Glove Length<br>- Palm Width | ASTM D6319 | 0.05mm min<br>0.05mm min<br>>230mm<br>X Small :70 $\pm$ 10mm<br>Small :80 $\pm$ 10mm<br>Medium :95 $\pm$ 10mm<br>Large :110 $\pm$ 10mm<br>X Large :120 $\pm$ 10mm | 0.10mm<br>0.07mm<br>>240mm<br>X Small :70 $\pm$ 10mm<br>Small :80 $\pm$ 10mm<br>Medium :95 $\pm$ 10mm<br>Large :110 $\pm$ 10mm<br>X Large :120 $\pm$ 10mm | Different but within<br>the ASTM standard<br>Same |
| Powder Free | ASTM D6124 | < 2mg per glove | 0.20 mg/glove | Different but within the ASTM standard |

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| | | DEVICE PERFORMANCE | | |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| CHARACTERISTICS | STANDARDS | PREDICATE | SUBJECT DEVICE | COMPARISON<br>ANALYSIS |
| | | BLACK | BLACK | |
| | Primary Skin Irritation<br>- ISO 10993-10:2010<br>(E) & Consumer<br>Product Safety<br>Commission Title 16.<br>Chapter II, Part 1500 | Passes | The test material did not cause<br>an irritant response. The<br>Primary Irritant Response<br>Category is deemed 'Negligible' | Similar |
| Biocompatibility | Dermal Sensitization-<br>ISO 10993-10: 2010<br>(E) & Consumer<br>Product Safety<br>Commission, Title 16,<br>Chapter II, Part<br>1500.3 (c) (4) | Passes | The test material did not<br>produce a skin sensitization<br>effect in the guinea pigs. | Similar |
| | Cytotoxicity - MEM<br>Elution, ISO 10993-5:<br>2009 (E) | Passes | The test material demonstrated<br>a cytotoxic effect under the<br>condition of this study.<br>Grade 2 for 6.25% & 12.5%<br>Grade 4 for 25%, 50% & 100%<br>Additional test i.e. Acute<br>Systemic Toxicity was tested. | Different – but<br>additional test of<br>Acute Systemic<br>Toxicity is<br>conducted. |
| | | DEVICE PERFORMANCE | | |
| CHARACTERISTICS | STANDARDS | PREDICATE | SUBJECT DEVICE | COMPARISON<br>ANALYSIS |
| | | BLACK | BLACK | |
| Biocompatibility | Acute Systemic<br>Toxicity, ISO 10993-<br>11:2017 (E) | Not Applicable | The test item did not induce<br>any systemic toxicity in Swiss<br>albino mice. | Different. |
| Watertight (1000ml) | ASTM D5151:2019 | In accordance with ASTM<br>D6319-10 and ASTM D5151-06<br>(reapproved 2011), G-1, AQL<br>2.5 | Gloves passed AQL 1.5 | Different, but<br>within the ASTM<br>standard. |
| Intended use /<br>Indications for use | - | The Nitrile Powder Free patient<br>examination glove is a non-<br>sterile disposable device<br>intended for medical purpose<br>that is worn on the examiner's<br>hands or finger to prevent<br>contamination between patient<br>and examiner. | A patient examination glove is a<br>disposable device intended for<br>medical purposes that is worn<br>on the examiner's hand or<br>finger to prevent contamination<br>between patient and examiner. | Same |
| Size | Medical Glove<br>Guidance Manual -<br>Labeling | X Small<br>Small<br>Medium<br>Large<br>X Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Same |
| Single use | Medical Glove<br>Guidance Manual -<br>Labeling | Yes | Single Use | Same |
| Sterility Status | Medical Glove<br>Guidance Manual -<br>Labeling | Non-Sterile | Non-Sterile | Same |

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There are no significant differences between the two products and they are the same or similar in terms of intended use, materials design, physical properties, thickness and biocompatibility test.

#### 6.0 Summary of Non-Clinical Testing

The performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as per below.

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| Test Method | Standard | Purpose of Testing | Acceptance Criteria | | Results | | Status | |
|---------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------|--------------|--------------|-------------|---------|------|
| | | | Before aging | After aging | Before aging | After aging | | |
| Physical Properties | ASTM D412<br>(Standard Test<br>Method for<br>Vulcanized Rubber<br>and Thermoplastic<br>Elastomers-Tension) | To evaluate the<br>tensile (tension)<br>properties of glove. | Tensile<br>strength | Min 14.0 MPa | Min 14.0 MPa | 30.9Mpa | 34.2Mpa | Pass |
| | | | Ultimate<br>elongation | Min 500% | Min 400% | 583% | 538% | Pass |

| Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | Results | Status |
|----------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Watertight | ASTM D5151<br>(Standard Test<br>Method for<br>Detection of Holes<br>in Medical Gloves) | To detect holes<br>that leak water<br>and thereby<br>compromise the<br>usefulness of the<br>glove. | Sample size: 315 pcs<br>Inspection level: G1<br>AQL: 1.5, Acceptance No. 10 | The batch size for this<br>sampling is 150,001 to<br>500,000. Hence,<br>according to the single<br>sampling plan GI, the<br>sample to be drawn is<br>under code M<br>equivalent to 315<br>pieces with accept 10<br>and reject 11 to be<br>accepted under AQL<br>1.5. During the test, 0<br>piece was found with<br>leaks. Hence it falls<br>within the acceptance<br>criteria. | Pass |

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| Test<br>Method | Standard | Purpose of<br>Testing | Glove<br>Size | Acceptance Criteria | | Results | | Status |
|----------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------|-----------------|------------------------------------------|---------------------|---------------------|-----------|---------|
| Dimension | ASTM D3767<br>Standard<br>Practice for<br>Rubber-<br>Measurement<br>of Dimensions | To measure the<br>length, width and<br>thickness<br>of<br>glove | X-Small | Length | Min 240 mm | Length | 251 mm | Pass |
| | | | | Width | $70 \pm 10$ mm | Width | 78.0 mm | Pass |
| | | | | Thickness | Finger - min 0.05mm | Thickness | 0.10 mm | Pass |
| | | | | | Palm - min 0.05mm | | 0.07 mm | |
| | | | Small | Length | Min 240 mm | Length | 250 mm | Pass |
| | | | | | Width | $80 \pm 10$ mm | Width | 88.0 mm |
| | | | | | Thickness | Finger - min 0.05mm | Thickness | 0.10 mm |
| | | | | | | Palm - min 0.05mm | | 0.07 mm |
| | Medium | | Length | Min 240 mm | Length | 251 mm | Pass | |
| | | | | | Width | $95 \pm 10$ mm | Width | 98.0 mm |
| | | | | | Thickness | Finger - min 0.05mm | Thickness | 0.10 mm |
| | | | | | | Palm - min 0.05mm | | 0.07 mm |
| | Large | | Length | Min 240 mm | Length | 250 mm | Pass | |
| | | Width | $110 \pm 10$ mm | Width | 108 mm | Pass | | |
| | | | Thickness | Finger - min 0.05mm<br>Palm - min 0.05mm | Thickness | 0.10 mm<br>0.07 mm | Pass | |
| | | | Length | Min 240 mm | Length | 249 mm | Pass | |
| | | X-Large | Width | $120 \pm 10$ mm | Width | 118 mm | Pass | |
| | | | Thickness | Finger - min 0.05mm<br>Palm - min 0.05mm | Thickness | 0.10 mm<br>0.07 mm | Pass | |

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| Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | Results | Status |
|--------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------|-------------------------------------------------------------------------|--------|
| Residual<br>Powder | ASTM D6124<br>(Standard Test<br>Method for Residual<br>Powder on Medical<br>Gloves) | To determine the<br>amount of<br>residual powder<br>and non-powder<br>solids found on<br>gloves. | Less than 2 mg per glove | Sample size : 5 pcs<br>Requirement : <2mg/glove<br>Result :0.20mg/glove | Pass |

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| | Biocompatibility Testing Information | | | |
|----------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Standard | Primary Skin Irritation – ISO<br>10993-10:2010 (E) &<br>Consumer Product Safety<br>Commission Title 16. Chapter<br>II, Part 1500 | Dermal Sensitization- ISO<br>10993-10: 2010 (E) &<br>Consumer Product Safety<br>Commission, Title 16, Chapter<br>II, Part 1500.3 (c) (4) | Cytotoxicity - MEM Elution,<br>ISO 10993-5: 2009 (E) | Acute Systemic Toxicity,<br>ISO 10993-11:2017 (E) |
| Results | The test material did not<br>cause an irritant response.<br>The Primary Irritant Response<br>Category is deemed<br>'Negligible' | The test material did not<br>produce a skin sensitization<br>effect in the guinea pigs. | The test material<br>demonstrated a cytotoxic<br>effect under the condition<br>of this study.<br>Grade 2 for 6.25% &<br>12.5%<br>Grade 4 for 25%, 50% &<br>100%<br>Additional test i.e. Acute<br>Systemic Toxicity was<br>tested. | The test item did not<br>induce any systemic<br>toxicity in Swiss albino<br>mice. |

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#### 8.0 Summary of Clinical Testing:

No clinical study is included in this submission.

#### 9.0 Conclusion

The conclusion drawn from the non-clinical tests demonstrate that the subject Black Nitrile Powder Free Patient Examination Glove, Non-Sterile is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K190942.