Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105)

K223903 · Semperit Investments Asia Pte , Ltd. · LZA · Jan 27, 2023 · General Hospital

Device Facts

• Record ID: K223903
• Device Name: Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105)
• Applicant: Semperit Investments Asia Pte , Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Jan 27, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This device is an ambidextrous patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Ambidextrous, non-sterile, single-use, powder-free nitrile examination glove; worn on examiner's hand/finger to provide barrier against infectious materials and contaminants. Tested for permeation resistance against chemotherapy drugs and Fentanyl per ASTM D6978. Available in S, M, L, XL sizes. Used in clinical settings by healthcare providers. Provides protection during patient examination and handling of hazardous drugs. Does not include software or algorithms.

Clinical Evidence

No clinical data. Bench testing only. Device demonstrated compliance with ASTM D6319 (dimensions, physical properties), ASTM D5151 (freedom from holes), ASTM D6124 (powder residue), ASTM D6978 (chemotherapy/Fentanyl permeation), and ISO 10993-10 (irritation/sensitization).

Technological Characteristics

Nitrile material; ambidextrous; powder-free; blue color. Complies with ASTM D6319, D5151, D6124, D6978, and ISO 10993-10. No energy source, connectivity, or software.

Indications for Use

Indicated for use as a patient examination glove to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs and Fentanyl. Warning: Do not use with Carmustine or Thiotepa.

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

• Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs (K171378)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 27, 2023

Semperit Investments Asia PTE. LTD. % Jay Mansour Regulatory Consultant / Principal Mansour Consulting LLC 845 Aronson Lake Court Roswell, Georgia 30075

Re: K223903

Trade/Device Name: Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, ODO Dated: December 27, 2022 Received: December 28, 2022

Dear Jay Mansour:

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 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.

# Allan G

For Bifeng Qian M.D., 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) K223903

# Device Name Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE Indications for Use (Describe) This device is an ambidextrous patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are: Carmustine (BCNU) (3.3 mg/ml). Permeation time: Carmustine (BCNU) has extremely low permeation times of 14.7 minutes. Cisplatin (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Cyclophosphamide (Cytoxan) (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Cytarabine (100 mg/ml). Permeation time: no breakthrough up to 240 minutes Dacarbazine (DTIC) (10.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Doxorubicin Hydrochloride (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Etoposide (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Fluorouracil (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes lfosfamide (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Methotrexate (25.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitomycin C (0.5 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitoxantrone (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Thiotepa (10.0 mg/ml). Permeation time: Thiotepa has extremely low permeation times of 13.6 minutes Vincristine Sulfate (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes The tested Opioid is: Fentanyl Citrate Injection (100mcg/2mL). Permeation: no breakthrough up to 240 minutes Please note that the following drugs have extremely low permeation times:

Carmustine: 14.7 minutes Thiotepa: 13.6 minutes

Warning: DO NOT USE WITH CARMUSTINE OR THIOTEPA

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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# K223903- 510(k) summary

# I Submitter

Device submitter: SEMPERIT INVESTMENTS ASIA PTE. LTD. 8 Jurong Town Hall Road, #29-03 To 06 The JTC Summit Singapore 609434

- Contact person: Jay Mansour Mansour Consulting LLC Regulatory consultant Phone [phone] Email [e-mail]
Date of preparation: January 27, 2023

#### II Proposed device

| 510(k) Number: | K223903 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade/Device Name: | Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl<br>SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104)<br>X-LARGE SIZE (NGPF105) |
| Regulation number: | 21 CFR 880.6250 |
| Regulation name: | Non-powdered Patient Examination Glove |
| Regulatory class: | Class I |
| Product code: | LZA (primary), LZC, OPJ, QDO |
| Review panel: | General Hospital |

# III Predicate devices

| 510(k) Number: | K171378 |
|--------------------|------------------------------------------------------------------------------------------------------|
| Trade/Device name: | Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs |
| Regulation number: | 21 CFR 880.6250 |
| Regulation name: | Non-powdered Patient Examination Glove |
| Regulatory class: | Class I |

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#### Product code: LZA (primary), LZC SEMPERIT INVESTMENTS ASIA PTE. LTD. Manufacturer:

# IV Device description

The Non-Sterile, Single use, Powder-free Examination glove, Blue, tested for use with Chemotherapy Drugs and fentanyl is provided in blue. It meets all the requirements of ASTM D6319. It is a medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves were tested for use with chemotherapy drugs as well as Fentanyl, per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug. It can be available in 4 specifications: S, M, L and XL.

# V Indications for use

This device is an ambidextrous patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The tested chemotherapy drugs are:

Carmustine (BCNU) (3.3 mg/ml). Permeation time: Carmustine (BCNU) has extremely low permeation times of 14.7 minutes.

Cisplatin (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Cyclophosphamide (Cytoxan) (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes

Cytarabine (100 mg/ml). Permeation time: no breakthrough up to 240 minutes Dacarbazine (DTIC) (10.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Doxorubicin Hydrochloride (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Etoposide (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Fluorouracil (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes lfosfamide (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Methotrexate (25.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitomycin C (0.5 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitoxantrone (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Thiotepa (10.0 mg/ml). Permeation time: Thiotepa has extremely low permeation times of 13.6 minutes

Vincristine Sulfate (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes The tested Opioid is:

Fentanyl Citrate Injection (100mcg/2mL). Permeation: no breakthrough up to 240 minutes

Please note that the following drugs have extremely low permeation times:

Carmustine: 14.7 minutes

Thiotepa: 13.6 minutes

Warning: DO NOT USE WITH CARMUSTINE OR THIOTEPA

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# VI Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:

- > ASTM D5151 Standard Test Method for Detection of Holes in Medical Gloves
- > ASTM D6124 Standard Test Method for Residual Powder on Medical Gloves
- > ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Application

> ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs

> ISO 10993-10: 2010 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization

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| Test<br>method | Purpose | Acceptance Criteria | Result | |
|-----------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|---------------------------------------------------------------|
| ASTM<br>D6319 | Dimensions | Extra-Small | Length: ≥220mm;<br>Width: 70±10 mm | |
| | | Small | Length: ≥220mm;<br>Width: 80±10mm | |
| | | Medium | Length: ≥230mm;<br>Width: 95±10mm | Pass |
| | | Large | Length: ≥230mm;<br>Width: 110±10mm | |
| | | Extra- Large | Length: ≥230mm;<br>Width: 120±10mm | |
| | | Thickness (mm):<br>Finger: ≥0.05<br>Palm: ≥0.05 | | Pass |
| | Physical properties | Before<br>Aging | Tensile<br>Strength ≥14MPa<br>Ultimate<br>Elongation ≥500% | Pass |
| | | After<br>Aging | Tensile<br>Strength ≥14MPa<br>Ultimate<br>Elongation ≥400% | Pass |
| | | | | |
| ASTM<br>D5151 | Freedom from holes | Shall comply with freedom from holes (AQL = 2.5)<br>when tested in accordance with ASTM D5151. | | Pass |
| ASTM<br>D6124 | Powder-free Residue | Have a powder residue limit of 2.0 mg in<br>accordance with ASTM D6124. | | Pass |
| ISO<br>10993-10 | To determine if the<br>finished device<br>material is an irritant. | Non-irritating | | Under the conditions of<br>the study not an irritant/<br>Pass |
| ISO<br>10993-10 | To determine if the<br>finished device<br>material is a sensitizer. | Non-sensitizing | | Under conditions of the<br>study, not a sensitizer. /<br>Pass |
| | Resistance to<br>permeation by<br>Fentanyl | No breakthrough when tested for permeation with<br>Fentanyl in accordance with ASTM D6978. | | Pass |
| ASTM<br>D6978 | Resistance to<br>Permeation by<br>Chemotherapy Drugs | Covered in predicate device 510(k) K171378 for<br>Carmustine (BCNU) (3.3 mg/ml)<br>Cisplatin (1.0 mg/ml)<br>Cyclophosphamide (Cytoxan) (20.0 mg/ml)<br>Cytarabine (100 mg/ml)<br>Dacarbazine (DTIC) (10.0 mg/ml)<br>Doxorubicin Hydrochloride (2.0 mg/ml)<br>Etoposide (20.0 mg/ml)<br>Fluorouracil (50.0 mg/ml)<br>Ifosfamide (50.0 mg/ml)<br>Methotrexate (25.0 mg/ml)<br>Mitomycin C (0.5 mg/ml)<br>Mitoxantrone (2.0 mg/ml)<br>Paclitaxel (Taxol) (6.0 mg/ml) | | Pass |

Table 1 Summary of Non-Clinical Performance Testing

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| | Vincristine Sulfate (1.0 mg/ml)<br>Thiotepa (10.0 mg/ml) | |
|--|----------------------------------------------------------|--|
| | | |

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# VII Clinical Test Conclusion

No clinical study is included in this submission.

# VIII Summary of Technological characteristics

| | Subject device | Predicate device | Comments |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | SEMPERIT INVESTMENTS ASIA PTE. LTD. | SEMPERIT INVESTMENTS ASIA PTE. LTD. | N/A |
| 510(k) number | TBD | K171378 | N/A |
| Device trade or<br>proprietary name | Non-Sterile, Single use, Powder-free<br>examination glove, Blue, tested for use<br>with Chemotherapy drugs and fentanyl | Non-Sterile, Powder-free Examination<br>glove, Blue, tested for use with<br>Chemotherapy Drugs | Different: except the addition of Fentanyl for<br>subject device, it is identical |
| Device Classification<br>Name/ Regulation number | Patient Examination Glove<br>21 CFR Part 880.6250 | Patient Examination Glove<br>21 CFR Part 880.6250 | Identical |
| Product Code | LZA (primary), LZC, OPJ, QDO | LZA (primary), LZC | Different: added two product codes |
| Indications for use | This device is an ambidextrous patient<br>examination glove that is a non-sterile,<br>single use, disposable device intended<br>for medical purposes, worn on the<br>examiner's hand or finger to prevent<br>contamination between patient and<br>examiner.<br>The tested chemotherapy drugs are:<br>Carmustine (BCNU) (3.3 mg/ml).<br>Permeation time: Carmustine (BCNU)<br>has extremely low permeation times of<br>14.7 minutes.<br>Cisplatin (1.0 mg/ml). Permeation time:<br>no breakthrough up to 240 minutes<br>Cyclophosphamide (Cytoxan) (20.0 mg/<br>ml). Permeation time: no breakthrough<br>up to 240 minutes Cytarabine (100 mg/<br>ml). Permeation time: no breakthrough<br>up to 240 minutes Dacarbazine (DTIC)<br>(10.0 mg/ml). Permeation time: no<br>breakthrough up to 240 minutes<br>Doxorubicin Hydrochloride (2.0 mg/ml).<br>Permeation time: no breakthrough up to<br>240 minutes<br>Etoposide (20.0 mg/ml). Permeation<br>time: no breakthrough up to 240<br>minutes Fluorouracil (50.0 mg/ml).<br>Permeation time: no breakthrough up to<br> | This device is an ambidextrous patient<br>examination glove that is a non-sterile,<br>single use, disposable device intended<br>for medical purposes, worn on the<br>examiner's hand or finger to prevent<br>contamination between patient and<br>examiner. The tested chemotherapy<br>drugs are:<br>Carmustine (BCNU) (3.3 mg/ml).<br>Permeation time: Carmustine (BCNU) has<br>extremely low permeation times of 14.7<br>minutes.<br>Cisplatin (1.0 mg/ml). Permeation time:<br>no breakthrough up to 240 minutes<br>Cyclophosphamide (Cytoxan) (20.0<br>mg/ml). Permeation time: no<br>breakthrough up to 240 minutes<br>Cytarabine (100 mg/ml). Permeation<br>time: no breakthrough up to 240 minutes<br>Dacarbazine (DTIC) (10.0 mg/ml).<br>Permeation time: no breakthrough up to<br>240 minutes<br>Doxorubicin Hydrochloride (2.0 mg/ml).<br>Permeation time: no breakthrough up to<br>240 minutes<br>Etoposide (20.0 mg/ml). Permeation<br>time: no breakthrough up to 240 minutes<br>Fluorouracil (50.0 mg/ml). Permeation<br>time: no breakthrough up to 240 minutes<br>Ifosfamide (50.0 mg/ml). Permeation<br>time: no breakthrough up to 240 minutes<br>Methotrexate (25.0 mg/ml). Permeation<br>time: no breakthrough up to 240 minutes<br>Mitomycin C (0.5 mg/ml). Permeation<br>time: no breakthrough up to 240 minutes<br>Mitoxantrone (2.0 mg/ml). Permeation<br>time: no breakthrough up to 240 minutes<br>Paclitaxel (Taxol) (6.0 mg/ml).<br>Permeation time: no breakthrough up to<br>240 minutes<br>Thiotepa (10.0 mg/ml). Permeation time:<br>Thiotepa has extremely low permeation<br>times of 13.6 minutes<br>Vincristine Sulfate (1.0 mg/ml).<br>Permeation time: no Breakthrough up to<br>240 minutes.<br>DO NOT USE WITH CARMUSTINE OR<br>THIOTEPA | Different<br>Subject device includes Fentanyl, while<br>predicate device does not. Other than for<br>Fentanyl, the indications for use are identical.<br>Note: Adding the Fentanyl to the indication<br>does not affect the intended use. The device's<br>intended use is it would be worn on the hand<br>for medical purposes to provide a barrier<br>against potentially infectious materials and<br>other contaminants. Therefore, there are no<br>differences to the intended therapeutic,<br>diagnostic, prosthetic, or surgical use of the<br>device, and therefore the change in the<br>indication for use (by adding Fentanyl) does<br>not affect the safety and effectiveness of the<br>device when used as labeled. |
| Materials | Nitrile | Nitrile | Identical |
| | | | |
| Standards used | 1. ISO 10993-10<br>2. ASTM D6319-19<br>3. ASTM D6124-06 (reapproved 2017)<br>4. ASTM D5151-19<br>5. ASTM D6978-05 (reapproved 2019)<br>6. ISO 2859-1<br>7. ASTM D412-16e1<br>8. ASTM D3767-03 (2020)<br>9. ASTM D573-04 (2019) | 1. ISO 10993-10<br>2. ASTM D6319-10 (reapproved 21015)<br>3. ASTM D6124-06 (2011)<br>4. ASTM D5151-06<br>5. ASTM D6978-05 (re-approved 2013)<br>6. ISO 2859-1<br>7. ASTM D412-16<br>8. ASTM D3767-03 (2014)<br>9. ASTM D573-04 (2015) | Identical, with justification provided below, following the same numbering sequence:<br>1. See biocompatibility below<br>2. The changes did not affect product design, production and compliance<br>(1st change: section 1.5. 2nd change: adding calculation options instead of actual cutting. 3rd change: limitation on accelerated aging option based on natural aging. 4th change: size XXL is introduced in the revised standard BUT it is NOT added in this submission). Recognition number is updated from 6-244 to 6-446 |
| | | | 3. No changes in the standard.<br>Recognition number 6-178 remains the same. |
| | | | 4. The changes did not affect product design, production and compliance<br>(1st change: section 1.7. 2nd change: temperature of the water leak test). Recognition number is updated from 6-175 to 6-424 |
| | | | 5. No change in the standard. Recognition number 6-147 remains the same |
| | | | 6. No change in the standard. Recognition number was updated from 5-62 to 5-88 |
| |…