The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by chemotherapy Drugs.
A powder-free 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 .In addition these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 standards ,Practice for assessment of Medical Glove to Permeation by chemotherapy Drugs . It is for overthe-counter use.

Device Description

The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with claiming, this product contain Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and non sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

AI/ML Overview

This document outlines the acceptance criteria and supporting studies for the "Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs" (K152542).

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria	Reported Device Performance (K152542)
Product Code	LZA, LZC	LZA, LZC
Intended Use	A powder-free 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. The device is for over-the-counter use.	Meets criteria. Additionally, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by chemotherapy Drugs.
Material Use	Nitrile compound	Nitrile compound
Color	Blue	Blue
Sterility/Single Used	Non sterile, Single used	Non sterile, Single used
Dimensions (Overall Length, Width, Thickness)	Overall Length (mm): Min 270mmWidth (±5mm): Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mmThickness at Palm (mm): Min; 0.10 mmThickness at Finger Tip (mm): Min 0.10 mm	Meets ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves)
Biological Evaluation - Primary Skin Irritation	Test article should be a non-irritant.	Under the conditions of this study, the test article was a non-irritant.
Physical Properties (Before Ageing)	Tensile Strength (MPa): >= 14minUltimate Elongation (%): >= 500min	Meets ASTM D6319-10
Physical Properties (After Aging)	After Aging at 70°C for 168 hrs @ 100°C for 22 hrs:Tensile Strength (MPa): >= 14minUltimate Elongation (%): >= 400min	Meets ASTM D6319-10
Biological Evaluation - Dermal Sensitization Assay	Test article should be a non-sensitizer.	Under the conditions of this study, the test article was a non-sensitizer.
Resistance against Chemotherapy Drugs	Minimum Breakthrough Detection time in minutes (0.01 µg/cm²/minute) based on ASTM D6978-05 for specified drugs.	Carmustine (BCNU) (3.3mg/ml): 20.1 minutesCyclophosphamide (20mg/ml): > 240 minutesCisplatin (1.0mg/ml): > 240 minutesDoxorubicin Hydrochloride (2 mg/ml): > 240 minutesEtoposide (20mg/ml): > 240 minutesFluorouracil (50mg/ml): > 240 minutesMethotrexate (25mg/ml): > 240 minutesPaclitaxel (6mg/ml): > 240 minutesThiotepa (10mg/ml): 50.6 minutes
Freedom from Pinholes	AQL 2.5, Inspection Level G-1	Meets ASTM D5151-06
Residual Powder	< 2.0 mg/pc	Meets ASTM D6124-06
Low Dermatitis Potential Claim	No clinical evidence of residual chemical additives that may induce Type IV allergy in human subjects (based on Modified Draize 95 test).	No clinical evidence presence of residual chemical additives that may induce Type IV allergy in human subject.

2. Sample Size Used for the Test Set and Data Provenance

The document details testing for various attributes, with specific sample sizes and testing methods mentioned.

Mechanical Properties (Dimensions, Physical Properties, Freedom from Pin-holes, Residual Powder): The testing was conducted according to ASTM D6319-10, ASTM D5151-06, and ASTM D6124-06. These standards typically specify sampling plans (e.g., AQL levels for pinholes) which define the sample sizes. The document states "Gloves meet all the specification listed in ASTM D 6319-10" and "Meets ASTM D5151-06" and "Meets ASTM D6124-06", indicating adherence to these sampling requirements. Specific numerical sample sizes for each test are not explicitly provided in the summary, but are implied by reference to the ASTM standards.
Resistance Against Chemotherapy Drugs: Tested in accordance with ASTM D6978-05. The specific sample size used for this test is not explicitly stated in the provided text.
Low Dermatitis Potential Claim (Skin Sensitization):
- Sample Size: Initial stage with 30 human subjects, followed by an additional number of subjects to reach a total of a minimum of 205 individuals.
- Data Provenance: The study was conducted on "non sensitized adult human subjects, who reasonably reflect the general user population in the US." This implies the data is prospective and representative of the US population, although the study itself was likely conducted by the manufacturer (Riverstone Resources Sdn. Bhd. in Malaysia) or a contract research organization.
Primary Skin Irritation: The specific sample size for this test is not explicitly stated but is also an in-vivo biological evaluation performed under ISO 10993-10:2010.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For physical and chemical properties (e.g., dimensions, tensile strength, chemotherapy drug permeation, pinholes, residual powder): The ground truth is established by objective, standardized laboratory tests according to recognized ASTM and ISO standards. These do not typically involve human "experts" in the way clinical studies do. The "ground truth" is the quantitative measurement or qualitative assessment (e.g., pass/fail) determined by the test method.
For Low Dermatitis Potential Claim (Modified Draize 95 test): This is a human subject study. The nature of the "ground truth" is the observed skin reaction (or lack thereof) in the human subjects. The qualification of individuals assessing these reactions (e.g., dermatologists) is not specified in the document but would typically involve trained medical professionals or researchers.

4. Adjudication Method for the Test Set

For physical and chemical properties: Adjudication is not applicable in the traditional sense. The results are objective measurements against predefined criteria.
For Low Dermatitis Potential Claim (Modified Draize 95 test): The document states that "The study completed on 205 non sensitized adult human subjects...gave all negative results. There was no clinical evidence of the presence of residual chemical additives..." This implies a direct observation and interpretation by the study's clinical staff. No specific adjudication method like "2+1" or "3+1" is mentioned for conflicting expert opinions, as the result was consistently negative for all subjects.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is a medical glove, and the studies described are performance and biocompatibility assessments, not diagnostic imaging or clinical decision support tools that would typically involve human readers or AI assistance in the way an MRMC study is designed.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical product (a glove), not an algorithm or a software device. The concept of "standalone performance" for an algorithm without human involvement does not apply here. The performance is the inherent performance of the glove itself.

7. The Type of Ground Truth Used

Physical/Chemical Properties: Standardized measurements and assessments from laboratory testing against established specifications (e.g., ASTM standards). This is objective laboratory data.
Chemotherapy Drug Permeation: Breakthrough detection time measured in accordance with ASTM D6978-05. This is objective laboratory data.
Primary Skin Irritation and Dermal Sensitization: In-vivo biological response observed in animal studies (for general biocompatibility, although human studies were done for sensitization). For the Low Dermatitis Potential Claim, the ground truth is the clinical outcome (presence or absence of irritation/sensitization) observed in human subjects.

8. The Sample Size for the Training Set

Not applicable. This document describes the performance of a manufactured medical device (glove), not an AI or machine learning model. Therefore, there is no "training set" in the context of algorithm development. The "training" for such a product would involve manufacturing process controls and quality assurance, which are not detailed as a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 24, 2015

Riverstone Resources Sdn. Bhd. Mr. Suresh Kumar Quality Assurance Manager Lot 55 & 56, No 13, Jalan Jasmin 2 Kawasan Perindustrian Bukit Beruntung Selangor 48300 MALAYSIA

Re: K152542

Trade/Device Name: Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: Undated Received: November 30, 2015

Dear Mr. 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K152542

Device Name

Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs

Indications for Use (Describe)

Minimum Breakthrough Detection time in minutes, 0.01ug/cm2/minute Chemotherapy Drugs and Concentration

20.1 Minutes

240 Minutes > 240 Minutes

240 Minutes

240 Minutes > 240 Minutes

240 Minutes

50.6 minutes

1)Carmustine (BCNU)(3.3mg/ml) 2)Cyclophosphamide (20mg/ml) 3)Cisplatin (1.0mg/ml)(1000ppm) 4)Doxorubicin Hydrochloride (2 mg/ml) 5) Etoposide (20mg/ml) 6) Fuorouracil (50mg/ml) 7)Methorexate (25mg/ml) 8)Paclitaxel (6mg/ml) 9)Thiotepa (10mg/ml)
The Maximum testing time is 240 minutes . Please note that the following drugs have low permeation time 1) Carmustine (BCNU)(3.3mg/ml) with Permeation time of 20.1 minutes 2) Thiotepa (10mg/ml) with Permeation time of 50.6 Minutes

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY -------

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(K) Summary Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with Tested for use with Chemotherapy Drugs

1.0 Submitter :

Company Name	: Riverstone Resources Sdn Bhd.
Company Address	: Lot 55 & 56,No 13, Jalan Jasmin 2Kawasan Perindustrian Bukit Beruntung48300,Bukit Beruntung,Selangor,Malaysia.
Contact Person	: Mr Suresh Kumar
Telephone No	: 603-60283033
Email	: qa1@riverstone.com.my

2.0 Preparation Date : 14th December 2015

3.0 Name of the Device

Trade Name / Proprietary Name : Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy drugs.

Device Name : Nitrile Patient Examination gloves.

Device Classification Name : Patient Examination gloves (21 CFR 880.6250).

Device Class : Class I.

Product Code :LZA , LZC.

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4.0) Identification of The Legally Marketed Device :

Class I patient Examination glove with claiming, this product contain Low Dermatitis Potential Claim and tested for use with Chemotherapy Drugs, Powder Free, LZC, which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.

Predicate Device: K050122. Powder Free Nitrile Examination (Blue) (This Product does not contain Thiuram and/or Carbamate and/or Thiazole) and K141623.EMG Blue Nitrile examination Gloves Powder Free with tested for use with Chemotherapy Drugs labeling claim

5.0 Device Description

6.0 Intended use of the Device

A powder-free 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 .In addition these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 standards ,Practice for assessment of Medical Glove to Permeation by chemotherapy Drugs . It is for overthe-counter use.

6.0 Specification for Nitrile gloves: 6.1 Dimension and Thickness of Gloves

Dimension	Size S	Size M	Size L	Size XL
Overall Length (mm)	270min	270min	270min	270min
Width (± 5mm)	85	95	105	115
Thickness at Palm (mm)	0.10min	0.10min	0.10min	0.10min
Thickness at Finger Tip (mm)	0.10min	0.10min	0.10min	0.10min

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6.1.2 Gloves Physical Properties and Holes

Measurement	Before Ageing	After Aging at 70°C for168 hrs @ 100°C for 22 hrs
Tensile Strength (MPa)	14min	14 Min
Ultimate Elongation (%)	500min	400min
Pin-hole Level	AQL 2.5Inspection Level G-1	AQL 2.5Inspection Level G-1

Gloves meet all the specification listed in ASTM D 6319-10

Characteristiભ્યું હિંદ્ર	AcceptanceCriteria	Powder FreeNitrile ExaminationGloves(Blue) withLow DermatitisPotential Claim andwith tested for usewith chemotherapydrugs,K152542	Powder FreeNitrileExaminationGloves (ThisProduct does notcontain Thiuramand/or Carbamateand/or Thiazole),K050122	EMG Blue NitrileExamination glovePowder free with testedfor use withChemotherapy Drugslabeling Claim,K141623
Product Code	LZA, LZC	LZA, LZC	LZA	LZA ,LZC
Intended use	A powder freepatientexaminationglove is adisposable deviceintended formedical purposesthat is worn onthe examiner'shand or finger topreventcontaminationbetween patientand examiner.The device is forover-the-counteruse.	A powder free patientexamination glove isa disposable deviceintended for medicalpurposes that is wornon the examiner'shand or finger topreventcontaminationbetween patient andexaminer. The deviceis for over-the-counter use.	A powder freepatient examinationglove is adisposable deviceintended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. Thedevice is for over-the-counter use.	A powder free patientexamination glove is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner.The device is for over-the-counter use.
Material use	Nitrile	Nitrile	Nitrile	Nitrile
	compound	compound	compound	compound
Colour	Blue	Blue	Blue	Blue
SterilitySingle used	Non sterile	Non sterile	Non sterileSingle used	Non sterileSingle used
	Single used	Single used
Non Sterile	Non Sterile	Non Sterile	Non Sterile	Non Sterile

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Dimensions	Overall Length(mm)Min 270mmWidth (±5mm)Size S =85mmSize M =95mmSize L =105mmSize XL =115mmThickness at Palm(mm)Min; 0.10 mmThickness atFinger Tip (mm)Min 0.10 mm	Meets ASTM D6319-10	Meets ASTM D6319-10	Appendix 2Meets ASTM D6319-10	Biological Evaluation on Medical Device --Primary Skin Irritation Test			Appendix 2
	Biological Evaluation on Medical Device -Primary Skin Irritation Test	Under the conditions of this study, the test article was a non-irritant.	Under the conditions of this study, the test article was a non-irritant.	Under the conditions of this study, the test article was a non-irritant.
Physical properties	Before AgeingTensile Strength(MPa)= 14minUltimateElongation (%)= 500minAfter Aging at70°C for168 hrs @ 100°Cfor 22 hrsTensile Strength(MPa)= 14minUltimateElongation (%)= 400min	Meets ASTM D6319-10	Meets ASTM D6319-10	Meets ASTM D6319-10	Biological Evaluation on Medical Device -Dermal Sensitization Assay	Under the conditions of this study, the test article was a non-sensitizer.	Under the conditions of this study, the test article was a non-sensitizer.	Under the conditions of this study, the test article was a non-sensitizer.
	Resistance against Chemotherapy Drugs	1) Carmustine (3.3mg/ml or 3000ppm), Breakthrough : 20.1 min.2) Cyclophosphamide (20mg/ml or 20,000ppm), Breakthrough time : >240 min.3) Cisplatin (1mg/ml or 1000ppm), Breakthrough time : > 240 min4)Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm), Breakthrough time : >240 min.5) Etoposide (20mg/ml or 20,000ppm), Breakthrough time : >240 min.6) Flourouracil (50mg/ml or 50,000), Breakthrough time : >240 min.7) Methotrexate (25mg/ml or 25,000ppm), Breakthrough time : > 240 min		1) Carmustine (3.3mg/ml or 3000ppm), Breakthrough: 4.5min.2) Cyclophosphamide (20mg/ml or 20,000ppm), Breakthrough time : >240 min.3) Cytarabine (100mg/ml or 100,000ppm), Breakthrough time : >240 min4)Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm), Breakthrough time : >240 min.5) Etoposide (20mg/ml or 20,000ppm), Breakthrough time : >240 min.6) Flourouracil (50mg/ml or 50,000), Breakthrough time: >240 min.7) Methotrexate (25mg/ml or 25,000ppm), Breakthrough time : > 240 min.
Freedom frompinholes	AQL 2.5Inspection LevelG-1	Meets ASTM D5151-06	Meets ASTM D5151-06	Meets ASTM D5151-06
Residual Powder	< 2.0 mg/pc	Meets ASTM D6124-06	Meets ASTM D6124-06	Meets ASTM D6124-06

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			Appendix 2
		8) Paclitaxel (6mg/mlor 6,000ppm),Breakthrough time :>240 min.	8) Paclitaxel (6mg/ml or6,000ppm), Breakthroughtime : >240 min.
		9) Thiotepa (10mg/mlor 10,000ppm),Breakthrough time :50.6 min.	9) Thiotepa (10mg/ml or10,000ppm),Breakthrough time : 6.88min.
Low DermatitisPotential Claim	1)ModifiedDraize 95 test	No Clinical evidencepresence of residualchemical additivesthat may induce TypeIV allergy in humansubject	No Clinicalevidence presenceof residualchemical additivesthat may induceType IV allergy inhuman subject

Resistance against Chemotherapy Drugs

Chemotherapy Drug and concentration	Minimum Breakthrough detection time in Minutes,0.01µg/cm²/minute
1)Carmustine (BCNU) (3.3mg/ml)	20.1 minutes
2)Cyclophosphamide (20mg/ml)	> 240 minutes
3)Cisplatin (1mg/ml)	> 240 minutes
4)Doxorubicin Hydrochloride (2 mg/ml)	> 240 minutes
5)Etoposide (20mg/ml)	> 240 minutes
6)Fluorouracil (50mg/ml)	> 240 minutes
7)Methorexate (25mg/ml)	> 240 minutes
8) Paclitaxel (6mg/ml)	> 240 minutes
9) Thiotepa (10mg/ml)	50.6 minutes

The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time. Carmustine (BCNU) (3.3mg/ml) Thiotepa (10mg/ml)

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7.0) Substantial Equivalent Based on Assessment of Non-Clinical Performance data

Testing was performed per ASTM D6319-10 , ASTM D5151-06, ASTM D6124-06,ISO 10993-10:2010 and 16 CFR Part 1500.41. The glove meet standards requirement referenced in section 6.0 above. Biocompatibility test indicates the gloves are not a contact skin sensitizer and not a primary skin irritant

8.0) Substantial Equivalent Based on Assessment of Clinical Performance Data

Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and tested for Use with Chemotherapy drugs were tested in accordance with Modified Draize -95 test , per FDA's guidance document "Guidance for Industry and FDA Reviewer/Staffs: Premarket Notification [510k] Submissions for testing for skin sensitization to chemical in natural Rubber Products".

The study was conducted in two stages. In the first, a population of 30 human subjects was tested to evaluate the product for the potential to cause irritation or sensitization. The second stage was initiated on a further number of subjects to a total of a minimum 205 individuals after the first stage has shown that the test product does not indicate a potential for inducing dermal irritation and does not shown sensitization capability

The study completed on 205 non sensitized adult human subjects, who reasonably reflect the general user population in the US, gave all negative results. There was no clinical evidence of the presence of residual chemical additives at the level that may induce type IV allergy in the un-sensitized general user population in the tested ariticle.

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9.0 Conclusion

Based on intended uses, technological characteristics and Non-Clinical performance data, Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis Potential Claim and with tested for Use with Chemotherapy drugs is substantially equivalent to the predicate device (K050122) and (K141623)

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.